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.
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.
- 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.
- 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