QC Data Reviewer

Highly Competitive Salary
  1. Permanent
  2. Analytical Chemistry, Biochemistry, Laboratory Technician
  3. United States
Waltham, USA
Posting date: 22 Jul 2020
SC.SB.30760

Proclinical is currently recruiting for a QC Data Reviewer with a pharmaceutical company located in Waltham, MA.

Job Responsibilities:

  • Verify that analytical testing results are accurate and complete, recognizing deviations in test procedures, and/or SOPs.
  • Write/review laboratory documents such as technical reports, analytical/microbiological test methods, specifications, SOPs validation documents, and transfer documents.
  • Review and revise training materials. Identify training needs within staff.
  • Command of ICH guidance (ICHQ), GMP requirements and FDA/EMEA regulations.

Skills and Requirements:

  • Sc. Degree or equivalent experience.
  • Demonstrated ability to participate in product projects.
  • Operational knowledge of analytical chemistry/microbiology (as applicable).
  • Full understanding of the requirements and application of GMP principles in a laboratory environment.
  • Effective verbal and written communication on an individual and group basis.
  • Capability to assist with validation and transfer test methods as applicable.
  • A demonstrated willingness to collaborate with colleagues to share best practices and /exchange ideas.
  • Supports other teams when required.
  • Technical expertise in a broad range of (bio)analytical methodologies, understands training methods and practices to ensure that staff are trained to employ these techniques to a high standard (as applicable).
  • Experience reviewing development reports, batch records; working with CDMOs is a plus.

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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