Quality Control Analyst
747 Grayson Street Berkeley, CA 94710 US
Target Pay Rate: 35-51.13/hr **salary will be commensurate with experience
QC Stability - The QC Stability team coordinates, creates and executes stability studies for commercial biotech products manufactured at the Berkeley site.
The selected candidate will be responsible for coordinating and executing stability studies to meet regulatory requirements for commercial biotech products. Candidate will also support Technical Registration Documents and other regulatory document updates. Additionally, support will be required for related investigations along with internal and external audits. Maintenance of the QC Stability laboratory areas and QC Stability documentation will also be required.
Position Duties and Responsibilities:
- Setup and initiate stability studies in LIMS and physically in the stability chambers.
- Support stability pulls with the team to pull the appropriate inventory from the stability chambers and submit to the labs for stability testing.
- Support management of stability, standards and controls inventory including periodic inventory checks, sample disposals, and close out of stability studies
- Follow GMP SOPs for management of stability, standards and controls program.
- Support lab and equipment maintenance including equipment cleaning, commissioning/decommissioning activities
- Support OOS investigations related to stability, standards and controls.
- Support statistical analysis of stability data and OOT investigations * Support maintenance of Controlled Temperature Environment (CTE) equipment.
- Support regulatory audits including internal compliance audits.
- Collaborate with groups within QC and outside of QC for management of the stability program for a product and OOS investigations.
- Education Minimum Requirement Bachelor's Degree
- Experience with a cGMP and global regulatory compliance organization is required.
- Experience with Reference Material Programs or Stability Programs and data evaluation per ICH Guidance is highly desirable
- Experience with JMP software for statistical analysis and LIMS highly desirable
- Familiarity with client products and manufacturing processes highly desirable.
- Strong computer and communication skills are required.
- Ability to partner cross-functionally during discrepancy investigations
- Experience with equipment and analytical method validation is highly desirable
- Technical writing skills are required.
- Focus on Goals
- Focus on the Customer
- Continuously Improve
- Integrity and Commitment to Company Beliefs and Values
- Effective Problem Solving
Preferences - (list nice-to-haves such a specific knowledge items, certifications, skills, abilities, etc.)
- Familiarity with client products and manufacturing processes desirable
- Familiarity with SAP systems is highly desired.
- Previous experience is analytical or biochemical QC lab is preferred.
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