QC Technician – Microbiology

QC Technician – Microbiology

Baudette, MN

JOB OVERVIEW

QC Technician – Microbiology

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for working within the Microbiology Laboratory including preparing microbiological media, preparation of samples, maintaining glassware, monitoring and maintenance of equipment, and general Microbiology Laboratory support.

Position Responsibilities

Responsibilities include but are not limited to:

  • Prepares and initiates testing of microbiological media, including autoclaving, microbial bioburden, biological indicator testing, pH, etc.
  • Maintains Microbiology Laboratory glassware including autoclaving biohazardous materials, emptying and washing decontaminated glassware, autoclaving reusable supplies for testing.
  • Performs cGMP tasks as assigned including monitoring expiry dates, ordering supplies, restocking of disposables, maintaining SOP’s in area of responsibility, filing of documentation, reviewing logbooks and coordinating biohazardous disposal. 
  • Participates with Microbiologist in the preparation of samples for testing of finished products and raw materials, including water, and environmental monitoring.
  • Monitors and operates equipment including daily/annual temperature monitoring of refrigerators and incubators, daily autoclave maintenance and operation, cleaning of equipment, works with the maintenance team when any issues arise and IOP revisions. 
  • Performs other duties as assigned or requested.

About You

  • Associates degree with 3-5 years of experience of relevant pharmaceutical industry experience.
  • Excellent computer skills in a Microsoft Windows® environment.  Must include Excel®, Word and demonstrated skills in database management and record keeping.
  • Ability to Manage Multiple projects within a fast-paced environment. 
  • Ability to manage self-directed tasks to meet essential deadlines.
  • Attention to Detail.
  • Excellent Organizational and follow through skills.
  • Experience with data presentation and report writing is essential.
  • Fundamental knowledge of FDA Guidance documents and requirements. 
  • Must be able to work independently as well as within a team environment.
  • Strong interpersonal skills.
  • Demonstrated understanding of biohazards, aseptic techniques. 
  • Must be able to follow and prepare written procedures.
  • Ability to lift up to 30 lbs.

Benefits & Perks

  • Medical
  • Dental
  • Vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (10)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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Supervisor, Quality Control

Supervisor, Quality Control

Baudette, MN

JOB OVERVIEW

Supervisor, Quality Control

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for managing and directing, a professional group of analysts engaged in physical and chemical testing of raw materials, packaging components, in-process materials, and finished drug products to determine conformance with specifications.  This position is responsible for day to day scheduling of analyst responsibilities to ensure production needs are being met and that the laboratory is in conformance with cGMPs.  Additional responsibilities include conducting and writing laboratory investigations, notifying Quality Assurance of potential product quality issues, coordinating contract lab testing, revising SOP’s, IOP’s and other laboratory related documents.  Lastly, this individual enforces company policies and directives that apply to the department.

Position Responsibilities

Responsibilities include but are not limited to:

  • Manage and direct a group of analysts effectively so company goals and objectives are met, provide input on resources availability and needs to support production and project plans/sales goals, and coordinates work schedules with other departments. Develops plans and timelines to assure analytical support.  Assures effective and efficient utilization of resources.  Establishes work priorities and expectations.  Delegates authority and responsibility for the accomplishment of planned work.  Provides direction and feedback for timely work accomplishment.  Manages external laboratory resources to handle overflow laboratory support.
  • Provides training and enforces policies and procedures. Assures systems and procedures are adequate by developing, reviewing, and approving procedures to assure compliance with governing regulations, filed applications, and quality standards.  Identifies deficiencies and implements corrective actions.  Provides technical expertise to support investigations, protocols and procedures outside the laboratory.  Monitors training, performance and development of professional staff and provides feedback.
  • Performs reviews of data collected under approved test methods, investigational plans, and protocols in accordance with governing SOP’s. Approves all analytical data and results and releases to Quality Assurance. Work with analysts to correct deficiencies, mentor to assure understanding.
  • Notifies Quality Assurance in the event of a potential product quality issues and conducts and writes laboratory investigations. Ensures timely implementation and closures of CAPAs.
  • Performs other duties as assigned or requested.
 

About You

  • Working knowledge of GMP and pharmaceutical technology is preferred, plus excellent organization and interpersonal skills are required. 
  • Bachelor’s Degree in Chemistry, Microbiology, or related field.
  • Education, training, or certification in Management and Leadership
  • 1 year experience in a leadership role in an analytical laboratory in the pharmaceutical industry.
  • 4 years’ experience in an FDA regulated laboratory in the pharmaceutical industry.
  • Ability to follow, prepare and explain technical matters and procedures.
  • Ability to make decisions independently after appropriate input from areas that will be affected.
  • Ability to manage multiple projects and competing priorities.
  • Ability to perform under stressful situations
  • Demonstrated expertise of Laboratory cGMPs
  • Excellent leadership, communication, and interpersonal skills

Preferred Education

  • Advanced education in Management or Business Administration.
  • Post graduate degree in Analytical Chemistry, or other relevant area.

Preferred Experience

  • 5 years’ experience in an analytical laboratory in the pharmaceutical industry.

Benefits & Perks

  • Medical
  • Dental
  • Vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (10)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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Accounts Receivable Associate

Accounts Receivable Associate

Princeton, NJ

JOB OVERVIEW

Accounts Receivable Associate

About Us

ANI Pharmaceuticals, Inc. is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products. Our team is focused on delivering sustainable growth by building a successful Purified Cortrophin Gel franchise, strengthening our generics business with enhanced development capability, innovation in established brands and leveraging our North American manufacturing capabilities.

About the Role

This position is responsible for various duties as assigned within the Accounts Receivable area

Position Responsibilities

Responsibilities include but are not limited to:

  1. Apply an emerging understanding of customer Terms & Conditions to key activities
  2. Daily cash receipts entry and check allocations to A/R subledger
  3. Daily accruals associated with daily sales
  4. CN/DN (Credit Note / Debit Note) entry and allocation to A/R subledger
  5. Direct Invoicing
  6. Month End duties related to A/R function
  7. Customer Account reconciliations and understanding of customer accounts
  8. Raise emerging issues to Manager for resolution
  9. Credit/Collections
  10. Cash Projections
  11. Chargeback Log Maintenance
  12. Computer System Reporting
  13. Miscellaneous reporting/filing
  14. Performs other duties as assigned or requested

About You

Job Requirements

  1. Bachelor’s degree in Accounting/Finance/Business or 2-year associates degree in Accounting with 2+ years equivalent experience
  2. Excellent computer skills in Microsoft Windows Environment. Must include Excel with demonstrated aptitude for Access and/or database management.

Leadership Attributes:

  • Ability to manage multiple projects and competing priorities.
  • Ability to work well under pressure and to work within short deadlines.
  • Excellent organizational and multitasking skills, strong work ethic, and emphasis on attention to details.
  • Work independently while effectively communicating and coordinating work efforts with others.
  • Must have the ability to seek and implement opportunities to improve processes and/or drive process efficiency.

 

Benefits & Perks

  • Medical
  • Dental
  • Vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (10)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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QC Chemist/Sr. QC Chemist

QC Chemist/Sr. QC Chemist

Baudette, MN

JOB OVERVIEW

QC Chemist/Sr. QC Chemist

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

The QC Chemist position is responsible for independently performing testing in a pharmaceutical Quality Control laboratory. All work will be conducted in accordance with standard operating procedures and test methods. This includes performing testing on raw material, in-process and finished product samples. Execute compendia method validations, method transfers and validation support of new product development. Set up and confirm suitable operation of equipment and instrumentation. Collect data and generate/report results in accordance with governing test methods and SOPs.

Position Responsibilities

Responsibilities include but are not limited to:

  • Perform review of data collected under approved test methods and investigational plans and protocols, in accordance with governing SOPs. 
  • Provide accurate assessment of data integrity, and document findings.
  • Perform calibrations, preventive maintenance and repairs as needed on instrumentation. 
  • Qualify new equipment as assigned. 
  • Perform cGMP tasks such as laboratory housekeeping, auditing documentation and ordering supplies. 
  • Perform other duties as assigned or requested.

About You

  • Bachelors degree in chemistry, biochemistry, microbiology or closely related field/major.
  • QC Chemist – 1-3 years experience, with 2-5 years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry.
  • Sr. QC Chemist – 2-5 years experience, with 5+ years experience preferred, in a chemistry lab in the pharmaceutical, food, or other closely related industry.
  • Ability to read and follow written procedures
  • Attention to detail.
  • Ability to work with minimal supervision
  • Problem solving skills
  • Organization, communication and interpersonal skills.
  • Understanding of good laboratory practices and analytical techniques.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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QA Specialist I 2nd Shift

QA Specialist I 2nd Shift

Baudette, MN

JOB OVERVIEW

QA Specialist I 2nd Shift

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements. This includes, but is not limited to the following:

2nd Shift Monday -Friday 3:15 pm to 11:15 pm

Position Responsibilities:

Responsibilities include but are not limited to:

  • Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs.
  • Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging.
  • Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room.
  • Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements.
  • Perform other duties as assigned or requested.

About You

  • Bachelors degree in Chemistry, medical technology, microbiology or closely related field or major. 
  • Must have experience in an analytical laboratory, academic or otherwise.
  • Bachelors and/or post graduate education in Chemistry, Pharmacy or closely related field.
  • Experience following laboratory procedures and systems in Pharma or similarly regulated environment.

Benefits & Perks

  • Bachelors degree
  • 5 years experience working within Quality Assurance preferred
  • Computer skills
  • Previous work in a regulated environment
  • Problem solving skills
  • Ability to coordinate multiple tasks in a fast paced environment
  • Ability to read and follow procedures
  • Ability to work independently
  • Attention to detail
  • Excellent interpersonal skills
  • Excellent organizational and follow through skills
  • Excellent written and verbal communication skills
  • Knowledge of GMPs
  • Must be able to work within a team environment
  • Must be able to work possible shift changes
  • Must be able to travel occasionally
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QA Chemist

QA Chemist

Baudette, MN

JOB OVERVIEW

QA Chemist

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for evaluating and maintaining the overall Quality Assurance standards throughout ANI Pharmaceuticals, through review of documentation and auditing of Quality systems. This position may also support coordinating and compiling Annual Product Reviews and Reports, authoring Product Quality Complaint Investigations, and performing Quality Systems Auditing.

Position Responsibilities

Responsibilities include but are not limited to:

  • Perform review/disposition of manufactured raw materials, raw materials, packaging components, and labeling.
  • Perform Finished Product record review/disposition and review of Stability Data.
  • Maintain the Hold/Reject system and provide improvements to the system. 
  • Coordinate, assemble, and maintain Annual Product Reviews. 
  • Perform review of pre-approval / pre-printing labeling for ANI and contract packaged product.
  • Perform and author complaint investigations.
  • Perform Quality Systems Audits.
  • Perform other duties as assigned or requested.

About You

  • Bachelors degree in Chemistry, Engineering, Pharmacy or related sciences or applicable pharmaceutical experience. 
  • 5-10 years experience in pharmaceutical Quality Control and/or Quality Assurance.
  • Must have the ability to manage multiple projects within a fast-paced environment.
  • Experience following laboratory procedures and systems in Pharma or similarly regulated environment.
  • Must have the ability to organize and perform a wide variety of tasks efficiently with minimal supervision.
  • Ability to partner with others to form a team to identify and correct problems. 
  • Ability to read and follow procedures. 
  • Ability to work independently. Must have great attention to detail. 
  • Complete, up to date working knowledge of cGMPs. Excellent interpersonal skills. 
  • Excellent organizational and follow through skills. 
  • Excellent written and verbal communication skills. 
  • Must be able to make quality decisions in a timely manner with minimal or no supervision. 
  • Must be able to work in a team environment. 
  • Must have a working knowledge of Quality Science as well as working knowledge of Quality Assurance Activities.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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Operator I – Production 1st Shift

Baudette, MN

JOB OVERVIEW

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for operating pharmaceutical manufacturing/packaging machines and equipment.

1st Shift – Monday through Friday – 7:30 am to 3:30 pm
Starting Hourly Rate – $17.00 per hour

Position Responsibilities:

Responsibilities include but are not limited to:

  • Assists in material handling 
  • Equipment set-up and breakdowns 
  • Document processing according to Master Production Records 
  • Works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.

About You

  • This position requires a High School Diploma or equivalent, 1-2 years experience preferred.
  • Must be 18 years or older. 
  • Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards. 
  • Must be able to read, comprehend and follow written and verbal instruction with accuracy. 
  • Must have the ability to read, comprehend and follow written and verbal procedures. 
  • Must have excellent accuracy/attention to detail. 
  • Must have good basic communication and interpersonal skills. 
  • Must be able to lift a minimum of 25 pounds. Understanding of GMP requirements is preferred and a plus.
  •  Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions


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Operator I – Production 2nd Shift

Operator I – Production 2nd Shift

Baudette, MN

JOB OVERVIEW

Operator I – Production 2nd Shift

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

This position is responsible for operating pharmaceutical manufacturing/packaging machines and equipment.

2nd Shift – Monday through Friday – 3:15 pm to 11:15 pm
Starting Hourly Rate – $17.00 per hour – additional $1.25 per hour shift differential

Position Responsibilities

Responsibilities include but are not limited to:

  • Assists in material handling
  • Equipment set-up and breakdowns 
  • Document processing according to Master Production Records 
  • Works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean up.

About You

  • This position requires a High School Diploma or equivalent 
  • 1-2 years experience preferred. 
  • Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards, must be able to read, comprehend and follow written and verbal instruction with accuracy. 
  • Must have the ability to read, comprehend and follow written and verbal procedures. 
  • Must have excellent accuracy/attention to detail. 
  • Must have good basic communication and interpersonal skills. Understanding of GMP requirements is preferred and a plus.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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Operator I – Production 3rd Shift

Operator I – Production 3rd Shift

Baudette, MN

JOB OVERVIEW

Operator I – Production 3rd Shift

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

The Production Operator is responsible for operating pharmaceutical manufacturing and packaging machines and equipment.

3rd Shift – Sunday through Thursday – 11:15 pm to 7:15 am
Starting Hourly Rate – $17.00 per hour – additional $2.50 per hour shift differential

Position Responsibilities

Responsibilities include but are not limited to:

  • Material handling 
  • Equipment set-up and breakdowns 
  • Documents processing according to Master Production Records
  • Works with trained operators at assigned work centers to learn all aspects of the position, including batch record documentation, equipment set-up, operation and clean-up.

About You

  • This position requires a High School Diploma or equivalent
  • 1-2 years experience preferred. 
  • Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards, must be able to read, comprehend and follow written and verbal instruction with accuracy. 
  • Must have the ability to read, comprehend and follow written and verbal procedures. 
  • Must have excellent accuracy/attention to detail. 
  • Must have good basic communication and interpersonal skills. Understanding of GMP requirements is preferred and a plus. 
  • Must be able to wear personal protective equipment and hearing protection where provided and must be able to work varying shifts.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions
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Maintenance Mechanic I – 1st Shift

Baudette, MN

JOB OVERVIEW

About Us

ANI Pharmaceuticals, Inc., headquartered near the beautiful shores of Lake of the Woods in Baudette, MN, is a diversified bio-pharmaceutical company serving patients in need by developing, manufacturing, and marketing high quality branded and generic prescription pharmaceutical products.

About the Role

The Maintenance Mechanic is responsible for support and assistance of maintenance, repairs, and new installations for the facilities building, equipment and mechanical systems that are the responsibility of the Maintenance Department.

Position Responsibilities

Responsibilities include but are not limited to:

  • This position will support the 2nd Shift – Monday – Friday 3:15 pm to 11:15 pm.
  • Preventive maintenance to keep equipment in good working condition by following SOPs. 
  • Perform duties as needed for emergency and corrective repairs. 
  • Maintain documentation of all maintenance activities. 
  • Performs general maintenance duties throughout the facility. 
  • Performs other duties as assigned or requested

About You

  • Must have the ability to read, comprehend and apply written and verbal instructions accurately. 
  • Must have attention to detail. 
  • Must be able to work independently with minimal supervision. 
  • Must also be able to work well within a team. 
  • Must have troubleshooting and problem solving skills. 
  • Ability to wear personal protective clothing/equipment and hearing protection where required. 
  • Must be able to lift up to 40 lbs.

Benefits & Perks

  • Medical
  • Dental
  • vision
  • Life Insurance
  • Short-Term Disability and Long-Term Disability
  • Employee Assistance Program
  • 401(k) Savings Plan
  • Company Paid Holidays (11)
  • Paid Time-Off
  • Other Paid Leave
  • Employee Stock Purchase Plan (ESPP)
  • Opportunity to advance in company positions


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