Mallinckrodt Pharmaceuticals Quality Control Manager (Madison WI) in Madison, Wisconsin
Quality Control Manager (Madison WI)
JR000010646 Quality Control Manager (Madison WI) (Open)
ST-Madison - USA504
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.
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 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.
Education / Experience / Skills:
Bachelors degree in scientific discipline required. Masters 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 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.
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 the specific requirements of projects and/or investigations.
Locations: General Office and Laboratory Environment
Hours: Regular 1st shift
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.