Supervisor, Quality Control
Supervisor, Quality Control
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.
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.
- 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
- Advanced education in Management or Business Administration.
- Post graduate degree in Analytical Chemistry, or other relevant area.
- 5 years’ experience in an analytical laboratory in the pharmaceutical industry.
- 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