QC Data Reviewer job in Waltham, USA

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First Name*

Last Name*

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Phone Number*

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Are you an employer or a jobseeker?*

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Analytical Chemistry, Biochemistry, Laboratory Technician

Location: United States

This vacancy has now expired. Please see similar roles below...

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.

#LI-SB4

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