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Brisbane, CA 94005

Posted: 09/19/2023 Employment Type: Contract Job Category: Quality Job Number: 3662

Job Description

Responsibilities:

The Stability Manager/Senior Manager of CMC QC will work on one or more products
Manage, review, and organize stability data for relevant programs
Generate interim stability trending assessments and reports
Participate in stability programs for clinical and commercial products in accordance with ICH/FDA/EMA/USP/Ph. Eur. Guidelines
Keep track of contract lab stability time point pulls for different programs
Author, update, and revise CMC stability sections in support of regulatory filings
Address CMC stability inquiries per regulatory inquiries
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 stability data
Create Excel/JMP tables and graphs for stability data trending
Initiate and manage change controls, deviations and CAPA in 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 stability testing

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 stability methodologies is highly desirable
Experience in conducting stability studies per ICH Guidelines 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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