QC/QA Investigator

At-a-Glance:
Are you ready to build your career by joining a certified technology solutions and compliance consulting services company? If so, our client is hiring a QC Manager.

Position Type:

• Contract
• On-Site 

Required:

• 5 to 10 years of experience in Quality Control within pharmaceutical, biotech, or CDMO environments.
• Previous experience as QC Manager, QC Supervisor, QC Lead, or senior QC professional.
• Experience with GMP laboratory operations, documentation review, sample management, and product release support.
• Background in sterile drug product, biologics, aseptic manufacturing, or formulation development would be preferred.
• Good understanding of analytical testing and/or microbiology testing.
• Strong knowledge of GMP, FDA expectations, laboratory controls, and data integrity principles.
• Ability to work independently and manage priorities in a fast-paced environment.
• Strong communication and cross-functional collaboration skills.
• Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, or related field. 

Responsibilities:

• Supporting and managing daily QC laboratory operations, ensuring testing activities are completed on time and in compliance with internal procedures, client requirements, and applicable GMP regulations.

Key Responsibilities:

• Manage daily QC laboratory operations and support testing priorities.
• Oversee analytical and/or microbiology testing activities, depending on site needs.
• Support raw material, in-process, finished product, and stability testing processes.
• Review and approve QC documentation, test results, protocols, reports, and SOPs.
• Ensure compliance with cGMP, FDA requirements, internal procedures, and client expectations.
• Coordinate QC activities with Manufacturing, QA, Validation, Supply Chain, and Project teams.
• Support product release timelines from a QC perspective.
• Maintain inspection readiness within the QC area.
• Identify operational gaps and support process improvements within the laboratory.
• Provide guidance to QC team members and support workload prioritization.