Quality Control Manager (Stratatech, Madison, WI)

Mallinckrodt - Madison, WI (30+ days ago)3.3


The Quality Control (QC) manager is responsible for leading the QC function at Stratatech-a Mallinckrodt company. 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 Job 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 QC team, providing guidance and feedback to QC team members.
May perform additional duties as required.

Essential Job Requirements:
Bachelors/Masters degree in scientific discipline.

Minimum of 6-8 years Quality Control experience.

Supervisory experience required.

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.