Senior Specialist, Gmp Quality Assurance

5+ years

Not Disclosed

Remote

10 Sept. 13, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Senior Specialist, GMP Quality Assurance

Location: Remote
Job ID: 794
Number of Openings: 0

Company Overview:

Crinetics Pharmaceuticals, headquartered in San Diego, California, is dedicated to developing transformative therapies for endocrine diseases and related tumors. Founded by a team of visionary scientists, we are committed to rigorous innovation to enhance patient outcomes. As a growing company, we offer a dynamic, inclusive, and dog-friendly work environment. Join us in shaping the future of endocrine care and make a meaningful impact on patients' lives.

Position Summary:

The Senior Specialist, GMP Quality Assurance is pivotal in ensuring compliance with Good Manufacturing Practices (GMP) across our manufacturing and support operations. This role involves performing batch record reviews, analyzing analytical and microbiological testing, and supporting internal and external GMP audits. The ideal candidate will be a detail-oriented professional with extensive experience in GMP environments and a solid understanding of drug substance and drug product quality assurance.

Key Responsibilities:

Batch Record Review: Perform detailed reviews and disposition activities for clinical and commercial supplies.
Testing Review: Review and approve analytical and microbiological testing data for drug substances and drug products.
Quality Events Management: Coordinate and escalate Quality Events (Deviations, CAPAs) with Contract Manufacturing Organizations (CMOs) and QA management.
Documentation Oversight: Oversee QA aspects of API, drug product, and packaging operations, including reports, stability frameworks, and batch release documentation.
Audit Support: Support the QA team during internal and external GMP audits.
Metrics Compilation: Assist in compiling Quality metrics related to batch disposition, deviations, and CAPAs.
SOP Development: Write and review Standard Operating Procedures (SOPs) and internal investigations.
Additional Duties: Perform other duties as assigned.

Education and Experience:

Required:
- Bachelor’s degree in Chemistry, Engineering, or a related scientific discipline.
- Minimum of 5 years of relevant experience in a GMP environment, including drug substance, drug product, and packaging and labeling.
- Knowledge of FDA/EMA/ICH standards and regulations.
- Strong organizational skills and the ability to work in a fast-paced environment.
- Proficiency with MS Office, e-QMS systems (e.g., Veeva), and ERP systems.
Preferred:
- Experience with solid dosage forms.
- Prior experience with Electronic QMS systems (Veeva preferred).

Physical Demands and Work Environment:

Physical Activities: Requires sitting at a desk for extended periods, occasional walking, and lifting up to 25 lbs. The noise level is typically low to moderate.
Laboratory Activities: Experience in a biology and chemical laboratory environment required. Adherence to environmental health and safety requirements is essential.
Travel: Occasional travel up to 5% may be required.

Compensation and Benefits:

Base Salary Range: $83,000 - $110,000, depending on experience and education.
Total Rewards: Includes a discretionary annual bonus, stock options, ESPP, 401k match, and comprehensive health insurance (medical, dental, vision, and life insurance).
Paid Time Off: 20 days of PTO, 10 paid holidays, and a winter company shutdown.

Equal Opportunity Employer:

Crinetics is committed to providing equal employment opportunities without discrimination. We adhere to all applicable local, state, and federal laws regarding equal employment practices.

Vaccination Requirement:

Crinetics requires all employees and contractors to be fully vaccinated against COVID-19 as a condition of employment. Those unable to be vaccinated due to a medical condition or sincerely held religious belief may request a reasonable accommodation.

Application:

If you are a qualified candidate who is passionate about quality assurance and GMP compliance, we encourage you to apply. For more details about our company and this opportunity, visit our website.

#LI-MS1 #LI-remote

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Senior Specialist, Gmp Quality Assurance

Job Description

Job Title: Senior Specialist, GMP Quality Assurance

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