Job Title

Quality Control Manager

Requisition

JR000013615 Quality Control Manager (Open)

Location

CC-Port Allen - USA502

Additional Locations

Baton Rouge, LA, Port Allen, LA

Job Description

The Quality Control (QC) Manager is responsible for leading the QC function at the Port Allen, LA manufacturing facility. The QC Manager oversees quality inspections, material characterization, and qualification in production operations. They also ensure compliance in deviation investigations, validation studies, and site-level research.

Essential Functions:

• Lead development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the safety, purity, and functionality of materials, API, intermediate, 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. Mentor and develop the QC team, providing guidance and feedback to team members.

• Lead method qualification, validation efforts, and method transfer activities.

• Understand/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 programs related to QC testing equipment, analysis of the inspection activities and performance of data trending for annual product review reports.

• Supervise projects and communicate progress, timelines, and changes to project staff and manager.

• Provide competent representation of the quality control department during external audits and regulatory inspections.

• Work closely with Quality Assurance, Regulatory Affairs, Materials Management, and Manufacturing departments to ensure coordination and integration of QC activities with these departments.

• Assist with annual budget proposals and ensure compliance with approved budget.

• Ensure department work areas are maintained in a manner that is safe, clean, orderly, and complaint.

Minimum Requirements

• Bachelor's degree in scientific discipline

• 6+ years relevant Quality Control experience in a pharmaceutical, biotechnical or medical device environment with GC, FTIR, and GMP

• 4+ years with QC supervisory experience

• 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 with use of LIMS experience

• Independence with efficient time management and organizational skills

• Technical analytical skills

• Extensive knowledge of laboratory analyzers and inspection equipment used to perform chemical analyses and component inspections

Preferences:

• Masters or PhD degree in related field

• Quality certificate (ASQ CQE, CQM, CQA, etc.)

• Lean Manufacturing experience

Competencies:

• Problem-solving skills with an ownership mentality.

• Effective communication across organizational levels, internally and externally.

• Adaptability and rapid skill acquisition through training and research.

• Strong leadership, personnel development, and proficiency in key skills such as mathematics, computer literacy, communication, process optimization, and mechanical aptitude.

Organizational Relationship:

This position interacts closely with other members of QA/QC within the Port Allen, LA facility. This position is also expected to interact regularly with Manufacturing and Materials Management personnel. Cross-functional interactions with other groups can vary depending on the specific requirements of projects and/or investigations.

#LI-LM1

Mallinckrodt is a global specialty p harmaceutical 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.