QC Data Reviewer

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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