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QC Lab Compliance Manager
Pennington Rocky Hill Road, Building 21 Pennington, NJ 08534 Pennington, NJ 08534 US
Job Description
Position Overview
The Quality Control Lab Compliance Manager will focus on ensuring that laboratory operations meet regulatory standards and high-quality outputs, and be responsible for Stability and Sample receipt programs.
Key Responsibilities
- Quality Control Oversight: Oversee laboratory processes and workflows to ensure they meet quality and compliance standards. Develop and manage Stability and Sample receipt programs.
- Equipment Management: Review equipment logbooks, audit trails, preventative maintenance and calibration of equipment.
- Handle Non-Conformities: Investigate and resolve any compliance issues which arise in the laboratories including OOS and deviations. Initiate change controls and implement CAPA as needed.
- Conduct Audits and Inspections: Perform regular audits and inspections of laboratory practices and documentation to ensure compliance with regulatory standards.
- Technology Transfer and Method Validation: Lead protocol/report writing and training. Support the execution in coordination with Lab Managers.
- Training: Review and maintain training records for the department. Identify training needs and design programs to enhance staff competency. Responsible for creating and maintaining department training curriculum in QMS.
- Team Leadership: Lead and train a team of lab compliance officers and technicians.
- Compliance: Stay updated on industry regulations and ensure that the laboratory complies with all relevant laws and standards.
- Data Analysis and Reporting: Review and analyse data related to lab operations and compliance to identify trends and areas for improvement. Prepare detailed reports on lab compliance activities including data integrity and present findings in department and global meetings.
Qualifications
- Education: Bachelor’s Degree in a relevant field such as Chemistry, Biochemistry, Biotechnology or a related field.
- Experience: Generally, 5-7 years of lab experience in analytical method development, validation, and transfer in the biopharmaceutical industry. 1-3 years of investigation and audit experience in compliance with regulatory standards.
- Skills: Proficient or knowledgeable in HPLC, UPLC, Gas Chromatography, Atomic Absorption, Mass Spectrophotometry, pH, CCIT, Water Testing (TOC), Karl Fischer, CIEF, CE-SDS, ELISA and other analytical methods. Skilled in LIMS /Veeva/TrackWise/Master Control
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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