Laboratory Quality Assurance Supervisor

2 months ago


Charles City, Iowa, United States Cambrex Full time

Position Overview:

The Quality Control Supervisor will be responsible for overseeing laboratory operations, ensuring compliance with industry standards, and providing leadership to laboratory personnel. This role involves managing the workflow for the testing of raw materials, supplier qualifications, in-process evaluations, and stability assessments.

Key Responsibilities:

  • Direct the daily prioritization of quality control testing, optimizing staff and equipment resources.
  • Ensure the maintenance and calibration of laboratory instruments, including executing qualification and preventative maintenance tasks.
  • Facilitate training and provide troubleshooting support for laboratory staff.
  • Review completed laboratory tests to ensure timely data release and reporting.
  • Oversee the status of external sample testing as needed.
  • Maintain compliance with cGMP and other laboratory standards.
  • Draft and evaluate documentation related to laboratory operations and production activities.
  • Manage laboratory systems and maintain accurate records.
  • Provide on-call support for laboratory operations, covering various testing processes.
  • Collaborate with cross-functional teams to meet project timelines and deliverables.
  • Verify the accuracy of timecards and billing processes in accordance with site protocols.
  • Conduct quality control releases for raw materials, intermediates, and finished products.
  • Identify and document discrepancies, initiating investigations and corrective actions as necessary.

Qualifications and Skills:

  • Understanding of compliance within cGMP and regulatory frameworks.
  • Operational expertise with analytical instruments such as HPLC, GC, and FTIR.
  • Proficient in computer applications including word processing and data management.
  • Strong foundation in chemistry principles.

Education and Experience:

  • Bachelor's Degree in Chemistry, Pharmacy, or a related discipline is required; an advanced degree is preferred.
  • A minimum of 5 years of experience in a laboratory setting within the pharmaceutical sector, with a focus on manufacturing support.
  • Experience managing laboratory operations, particularly in a 24/7 environment, is advantageous.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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