Quality Control Manager (Stability)
|Monroe, North Carolina - United States
$80,000.00 - $105,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
We are actively seeking a Quality Control Manager, Stability to join our growing team. The primary purpose of this position is to manage all aspects of the stability program, including sample management and stability oversight, and ensure compliance with internal procedures, industry regulations and regulatory guidance documents.
Responsibilities include but are not limited to:
- Write, execute and manage the stability program in support of all three manufacturing phases, including oral solid dose, prefilled syringes/vials and nebulizer products.
- Ensure program is in alignment with FDA, ICH, WHO and other international agencies.
- Manage and facilitate completion of all stability-related tasks, including sample request, receipt, labeling, lay down procedure, calculation and execution of stability pulls.
- Organize and execute shipment to off-site storage and/or laboratory facilities.
- Coordinate with QC management for scheduling of stability sample analysis.
- Ensure data is managed and evaluated, including the creation, review and trending, to meet company, industry and regulatory requirements.
- Manage stability chambers, including daily monitoring and excursion evaluation.
- Write and maintain SOPs in support of the stability program.
- Comply with applicable FDA and international regulatory laws/standards and the Code of Conduct.
- Maintain knowledge of current regulatory requirements and standards as they pertain to the Stability and Quality Control departments.
- Represent company as appropriate in FDA, notified body, internal and other regulatory audits.
- Evaluate and continuously improve stability systems, quality and compliance with regulatory requirements, best practices and quality systems procedures.
- Be proactive with regulatory and industry changes.
- A minimum of a Bachelor’s degree in Science is required.
- A minimum of 5 years or more of experience in a Pharmaceutical Quality Control Laboratory environment, including experience with conducting stability studies.
- A minimum of 2 years or more of laboratory managerial experience, including involvement with regulatory audits.
- Experience with statistical applications for stability data evaluation and shelf-life determination.
Knowledge & Skills:
- Strong understanding of current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), Good Documentation Practices (GDP), cUSP and ICH Q1A (R2).
- Strong documentation skills are required, including writing SOPs, technical papers and investigations.
- Proficiency with Microsoft Word, Microsoft Excel and Power Point are required.
- Strong organizational and communicative skills are imperative.
- The ability to work independently and within a team structure and on multiple projects, with flexibility to adapt to changing priorities is required.
- Ability to lift 30 lbs and work within different extreme temperature/humidity environments as encountered in the various stability conditions.
- This candidate must be a technical expert and have excellent written and oral communication as well as interpersonal relationship skills.
University - Bachelor's Degree/3-4 Year Degree