- 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.
- 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
- Masters or PhD degree in related field
- Quality certificate (ASQ CQE, CQM, CQA, etc.)
- Lean Manufacturing experience
- 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.
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Quality Control Manager - Port Allen, United States - Mallinckrodt
Description
Job TitleQuality Control Manager
Requisition
JR 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:
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.
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