Quality Control Data Review Specialist
2 days ago
Cambrex High Point is seeking a highly skilled Quality Control Data Review Scientist to join our team. As a key member of our Quality Control department, you will play a critical role in ensuring the accuracy and compliance of laboratory data.
Key Responsibilities- Review and verify laboratory data and supporting documentation to ensure compliance with SOPs, compendial, and cGMP requirements.
- Utilize knowledge of instrument theory to thoroughly vet and review data, drawing conclusions based on collected data.
- Adhere to all EPA, FDA, cGMP, cGLP, and DEA regulations, as well as internal SOPs, related to the operation of the Quality Control lab and general operation of the chemical production facility.
- Follow all OSHA and company safety rules and practices.
- Identify data inaccuracies, incomplete inferences, and work directly with laboratory staff to provide guidance and direction on the correction of laboratory data packages.
- Verify and ensure that conclusions drawn on laboratory data are sound and accurate and representative of materials under examination.
- Provide off-shift coverage as required.
- Maintain laboratory inventory and notebooks.
- Responsible for assisting in training employees as needed.
- Coordinate and communicate project status.
- Proven ability to handle various project loads is preferred.
- Ability to work in a fast-paced, deadline-driven work environment.
- Strong attention to detail.
- Effective communication skills (oral, written).
- Ability to work well with others in a team environment.
- BS/BA in Chemistry/Biology or related science field required.
- Experience in a laboratory environment or quality assurance preferred.
Cambrex High Point is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With over 40 years of experience and a growing team of over 2,000 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
We strive to build a culture where all colleagues have the opportunity to engage in work that matters to our customers and the patients they serve, learn new skills and enjoy new experiences in an engaging and safe environment, and strengthen connections with coworkers and the community.
We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more.
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