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Quality Assurance Team Leader

2 months ago

Charles City, Iowa, United States Cambrex High Point Full time

Company Overview

At Cambrex, we value your contributions.

Cambrex is a prominent global contract development and manufacturing organization (CDMO) that specializes in providing drug substance, drug product, and analytical services throughout the entire drug lifecycle. With over 40 years of expertise and a dedicated team of more than 2,000 professionals, Cambrex is a reliable partner in both branded and generic markets for active pharmaceutical ingredient (API) and dosage form development and manufacturing.

Your Role is Important.

We aim to cultivate a workplace culture where all employees can:

  • Engage in meaningful work that impacts our clients and the patients they serve.
  • Acquire new skills and enjoy enriching experiences in a supportive and safe environment.
  • Build strong relationships with colleagues and the community.

We are committed to attracting and developing a dedicated team of valued professionals in our dynamic and expanding organization. Our competitive benefits package includes healthcare, life insurance, retirement planning, and more.

Your Career Path is Valuable.

Renowned for our customer-centric scientific and manufacturing excellence, as well as our unwavering commitment to quality and safety, we provide a variety of career and advancement opportunities across our global network. Together with our clients, we strive to enhance the quality of life for patients worldwide.

Position Summary

Reporting to the Manager, PSG, the PSG Supervisor will offer supervisory guidance, laboratory testing support, and technical leadership for laboratory personnel. The PSG Supervisor will oversee the laboratory workflow for daily testing of raw materials, supplier qualifications, in-process evaluations, and stability assessments while providing ongoing support for these activities.

Key Responsibilities

  • Coordinate daily prioritization of PSG testing, including staff and equipment utilization.
  • Maintain laboratory instruments, including equipment qualification and preventative maintenance programs, and assist with troubleshooting and minor repairs as needed.
  • Support training and troubleshooting initiatives for staff.
  • Review completed laboratory testing to facilitate the timely release of data, reports, and materials.
  • Oversee the status of offsite sample testing.
  • Ensure compliance with cGMP and general laboratory systems at defined levels.
  • Draft and review various documents to support laboratory efforts and production campaigns.
  • Maintain laboratory systems and documentation.
  • Provide laboratory on-call support coverage for all aspects of laboratory operations on a rotating basis.
  • Collaborate cross-functionally with other departments to ensure deliverables are met according to projected timelines.
  • Verify timecards and ensure SAP billing is completed accurately and timely.
  • Perform quality control release for raw materials, isolated intermediates, and finished products.
  • Identify discrepancies, author out-of-specification and deviation investigations, and implement associated corrective actions.

Qualifications and Skills

  • Familiarity with compliance requirements within cGMP, safety, and regulatory environments.
  • Operational knowledge of analytical instrumentation such as HPLC/UPLC, GC, IC, ICP, FTIR, UV-VIS equipment, and data stations.
  • Demonstrated computer proficiency, including word processing, spreadsheets, structural drawings, and databases, preferably in a Windows environment.
  • Strong foundational knowledge in chemistry.

Education, Experience & Licensing Requirements

  • Bachelor's Degree in Chemistry, Pharmacy, or a closely related field is required; an advanced degree is highly advantageous.
  • A minimum of 5 years of experience in a manufacturing support laboratory within the pharmaceutical industry, preferably with API and/or intermediate experience.
  • Hands-on experience in pharmaceutical laboratory management is required; management of a 24/7 lab operation is highly beneficial.

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.

Physical Requirements

Ability to lift and move items up to 25 pounds. Must be able to perform tasks requiring physical mobility, including standing for extended periods, bending, and reaching. Exposure to chemicals, moving parts, vibration, and noise within a laboratory setting may occur. Occasional travel for training or method transfer activities may be required. Flexibility to work different shifts may be necessary to meet critical deadlines.