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Posted: 09/11/2023 Employment Type: Contract Job Category: Quality Job Number: 3661

Job Description

Responsibilities:

The QC Data Review Manager/Senior Manager, of QC CMC will work on one or more products.
Perform review of analytical release and stability data, data integrity, laboratory documentation, stability reports, specifications, specification setting reports and other QC/analytical documents.
Participate in the qualification/validation of analytical test methods for all Product Quality parameters, specification setting, stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
Generate QC documents including, but not limited to, CoAs, specifications, specification justification reports, reference standard qualification reports and risk assessment
Work within QC and with QA and other team members to address review comments on QC/analytical documents
Manage/assist the document creations and reviews via Veeva Document System
Create and update batch analysis tables for release data
Create Excel/JMP tables and graphs/charts for release and stability data trending
Initiate and manage change controls, deviations and CAPA with Veeva Document System
Assist in OOS/OOT/Deviation investigations
Ensure compliance with current GMP’s in a manufacturing environment such that the products are assessed to agreed upon specifications in a timely manner in order to support lot release and stability testing.
Evaluate existing analytical method validation packages for accuracy and compliance with current ICH/FDA guidelines.

Requirements / Qualifications:

Bachelor’s degree in Biochemistry, Molecular Biology, Pharmaceutical Sciences or a related life science field
Quality Manager: 3 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
Senior Quality Manager: 5 plus years’ experience with analytical/QC experience in a GMP environment (Pharmaceutical or Biotech industries)
Working experience and knowledge in a wide variety of quality control release and stability methodologies is highly desirable
Good oral and written communication skills and a fast learner
Proficient in project and personnel management, excellent organizational skills and the ability to work on multiple projects with tight deadlines
Proficiency in MS Office, Word and Excel
Proficient in statistical analysis software desired (Excel/JMP)

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