Senior Specialist, GMP Quality (Operations) – Temp to Perm (Remote)
- Target start: ASAP
- Duration: 6 months with opportunity to extend and/or convert (conversion may occur before 6 months if the fit is strong)
- Schedule: Monday–Friday, EST time zone
- Location: Remote
- Compensation: $60–$75/hour (weekly hours: 40)
- Perm salary expectations: $85K–$100K
Overview
We are seeking a Senior Specialist, GMP Quality (Operations) to support Quality Unit efforts across the company and with Contract Manufacturing Organizations (CMOs). In this role, you’ll help ensure that clinical and commercial products meet established quality requirements, are released in accordance with GMP standards, and that critical quality activities—batch record review, product disposition, compliance documentation, complaints, CAPA oversight, and audit readiness—run efficiently and accurately. This is a temp-to-perm opportunity with the potential to extend and convert for the right fit.
Required Skills
- Experience in Quality Assurance (QA) within the Pharmaceutical or Biotechnology industry in an operational QA role
- Minimum 7 years of QA experience
- Ability to perform review of pre-executed and executed batch records for API, Bulk Drug Product, and Finished Drug Product, including data reviewed across functions to confirm procedures and specifications were followed
- Working knowledge to ensure timely disposition of clinical and commercial products in compliance with internal standards and local/international laws
- Experience supporting regulatory document reviews to ensure accuracy against source data
- Ability to process and maintain Product Quality Complaints as needed
- Experience supporting drafting and revisions of Quality Agreements as needed
- Strong GMP oversight capabilities, including:
- Product impact assessment and root cause analysis oversight for deviations
- Ensuring appropriate CAPA actions are identified, tracked, implemented, and closed in the QMS (e.g., Veeva)
- Strong verbal and written communication skills to work independently with minimal oversight and collaborate across teams in a fast-paced environment
- Knowledge of pharmaceutical quality expectations including:
- FDA cGMP regulations
- Eudralex and ICH guidances (and other relevant industry regulations)
- Understanding of product development and lifecycle, from discovery to commercialization
- Experience with CMC and regulatory filing requirements
- Preferred focus area: small molecules and oral dosage forms (highly preferred)
Nice to Have Skills
- Hands-on experience with analytical or QC work
- Additional familiarity with stability and quality review activities, including:
- GMP data review support for stability protocols, stability testing, method validation, and method transfers
- Experience partnering closely with CMC Analytical functions during technical and quality reviews
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Preferred Education and Experience
- B.S. in Life Sciences or related science degree (e.g., Chemistry, Biochemistry, etc.) required
- Advanced degree in a related field is a plus