1+ months

Stability Supervisor, Quality Control Analytical

Revance Therapeutics Inc.
Newark, CA 94560
  • Job Code
    122767875
Category: Quality & Validation
Location: Newark, California

Description

Position Summary

The QC Stability Supervisor will be responsible for improvement, development, implementation and maintenance of the stability programs and internal procedures and processes in compliance with regulatory requirements and commitments for clinical and commercial products. The individual will work closely within the QC organization and external laboratories to ensure testing completion and will review and trend the stability results.

Essential Duties/Responsibilities
  • Maintain stability programs in compliance with regulatory requirements and commitments for clinical and commercial products.
  • Perform testing for in-process, release and stability samples as needed
  • Author and/or revise internal procedures and develop and implement processes as part of continuous process improvements related to the stability program
  • Author or amend stability protocols, and author interim and final stability reports.
  • Maintain documentation associated with the conduct of a stability study, in accordance with internal procedures.
  • Review stability results real-time; report suspect out-of-specification results in timely manner to ensure appropriate immediate actions are taken.
  • Perform periodic review and analysis of stability results for comparability studies, shelf life, degradation rates, trending and trend limits.
  • Ensure stability chambers have been appropriately validated, calibrated and maintained.
  • Serve as the business owner and/or administrator for Stability Management software.
  • Manage and monitor stability inventory, milestones and detailed timelines for stability studies while providing transparent communication. These responsibilities may include overseeing stability activities at external laboratories, as applicable.
  • Coordinate the stability testing schedule and maintaining relationships with external laboratories to ensure timely completion and reporting of results for a stability time point.
  • Oversee inspections and inventory of stability samples annually for each study.
  • May author, or supervise QC analysts in the writing of, stability related quality system records, including their investigations.


Education

Minimum Required:

BS in Biochemistry, Chemistry or related Sciences

Preferred:

MS in related fields

Experience

Minimum Required:

5+ years in a GMP environment (pharmaceutical or biotechnology industry) with at least 2 of those years in a QC senior stability/analyst role

Knowledge, Skills and Abilities

Minimum Required:
  • Proven strong interpersonal, organization and problem-solving skills
  • Solid knowledge and understanding of US and international (e.g. EU, ICH, GXP) regulations and guidance applicable to stability of biological products or new chemical entities
  • Effective verbal and written communications skills, detail-orientated with the ability to work effectively in a fast paced, multi-disciplinary team environment
  • Knowledge of analytical, micro and protein methods is strongly preferred.


Preferred:
  • Excellent organizational skills with the ability to work on multiple projects with varying complexity and timelines
  • Experience with developing and implementation of QC stability programs for biologics drug substance and injectable drug product in a commercial environment
  • Experience with statistical analysis tools, e.g., SAS JMP
  • Experience with preparing regulatory documentation and inspection management




PI122767875
Posted: 2020-08-20 Expires: 2020-09-20

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Stability Supervisor, Quality Control Analytical

Revance Therapeutics Inc.
Newark, CA 94560

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