Full-Time Quality Control Manager
Job Description
Summary
The Quality Control (QC) Manager is responsible for leading the QC function. The role leads the development, implementation, and maintenance of QC functions such as lot release testing, stability, environmental monitoring, and quality inspection of incoming materials. This role provides QC function support to the organization and reports to the Director of Quality.
Essential Functions
Lead development and implementation of standards, methods and procedures for inspecting, testing and evaluating the safety, purity, and potency of materials and final products, ensuring materials and final products conform to approved specifications and regulatory requirements.
Manage functional area and direct reports to ensure daily tasks and business needs are met.
Write and revise Standard Operating Procedures (SOP), stability protocols, qualification protocols and other documents to support cGMP QC operations.
Lead method qualification and validation efforts.
Perform analyses and identify trends in the inspection of finished products, in-process materials and bulk raw materials, and recommend corrective actions as necessary.
Supervise the identification, installation, qualification, calibration and maintenance of QC testing equipment.
Coordinate third-party testing of Stratatech cell banks, raw materials, intermediate products, and final products.
Work closely with Quality Assurance, Regulatory Affairs, Clinical, Product Development, and Manufacturing departments to ensure coordination and integration of QC activities with these departments.
Mentor and develop the QC team, providing guidance and feedback to team members.
Perform Quality related activities periodically as necessitated.
Minimum Requirements
Education / Experience / Skills:
Bachelor’s degree in scientific discipline required. Master’s or PhD degree in related field preferred.
Minimum of 6-8 years relevant Quality Control experience in a pharmaceutical, biotechnical or medical device environment required. Biologics experience preferred.
Supervisory experience strongly preferred.
Ability to exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to analyze complex data to identify sources of variability or error and define corrective actions.
Independence with efficient time management and organizational skills.
Excellent written and verbal communication skills.
Environmental monitoring knowledge preferred.
Laboratory test method development preferred.
Organizational Relationship/Scope:
Position interacts closely with other members of QA/QC within Madison site. Position is also expected to interact regularly with Tech Ops, Manufacturing and Supply Chain. Cross-functional interactions with other groups can vary depending on the specific requirements of projects and/or investigations.
Working Conditions:
Locations: General Office and Laboratory Environment
How to Apply
If interested, please submit your application via the link below... https://mallinckrodt.wd5.myworkdayjobs.com/MallinckrodtCareers/job/ST-Madison---USA504/Quality-Control-Manager_JR00001326275 total views, 0 today