Crinetics Pharmaceuticals · 2 days ago

Senior Specialist, GMP Quality Assurance

San Diego, CA

Full-time

Onsite

Senior Level

$83K/yr - $110K/yr

5+ years exp

Wonder how qualified you are to the job?

Maximize your interview chances

BiotechnologyHealth Care

Hiring Manager

Malcolm Stewart

Insider Connection @Crinetics Pharmaceuticals

Discover valuable connections within the company who might provide insights and potential referrals, giving your job application an inside edge.

Responsibilities

Perform batch record review and disposition activities for Clinical and Commercial Supplies.

Review and approve analytical and microbiological testing data for Drug Substance and Drug Product.

Coordinate Quality Events with CMOs and escalate to QA management.

Oversee QA aspects of API, Drug Product, Packaging, and Labeling Operations.

Represent QA in internal and external team meetings.

Support QA team on internal and external GMP audits.

Write and review Standard Operating Procedures.

Compile metrics of Batch Disposition, deviations, CAPAs, etc.

Other duties as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

FDA/EMA/ICH StandardsManufacturing Equipment KnowledgeAnalytical Testing Equipment KnowledgeMS OfficeE-QMS (Veeva)ERP SystemsOrganizational SkillsTeamworkSolid Dosage ExperienceElectronic QMS Systems (Veeva)

Required

Bachelor’s degree in Chemistry, Engineering or any other scientific discipline and 5 years of relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labeling.

Demonstrate knowledge of FDA/EMA/ICH standards and regulations.

Demonstrate ability to effectively organize, and work in a fast-paced environment.

Demonstrate ability to function individually and in a team environment.

Equipment: Working knowledge of relevant manufacturing and analytical testing equipment and instrument.

Software Knowledge: MS Office, e-QMS (e.g. Veeva), ERP systems.