Quality Assurance Specialist

GForce Life Sciences; Irvine (CA); Hybrid; USD 60,000 - 80,000; Full time

Job summary

GForce Life Sciences is seeking a Quality Assurance Consultant for a biopharmaceutical client focused on eye care. This 6-month contract position involves ensuring compliance and supporting QA activities in early-phase clinical development. The ideal candidate has 7-10 years of experience in Quality Assurance within pharmaceuticals and a robust understanding of change controls and deviation management.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• 7-10 years of experience in Quality Assurance within the pharmaceutical industry.
• Experience in early-phase clinical development.
• Laboratory background with methodologies.

Responsibilities

• Support QA activities for early-phase clinical development programs.
• Ensure compliance with GMP in addition to internal policies.
• Review and approve change controls and deviation reports.

Skills

Strong knowledge of deviation and change control systems.

Experience with investigations using root cause analysis, CAPA and CAPA effectiveness

Education

Bachelor’s or advanced degree in life science or a related field

Job description

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This range is provided by GForce Life Sciences. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $80.00/hr

Direct message the job poster from GForce Life Sciences

Executive Recruiter at GForce Life Sciences

Consultant, Quality Assurance, Pharmaceutical

Summary

Our client, a biopharmaceutical company dedicated to developing and commercializing novel therapies for diseases with significant unmet needs, particularly in eye care, has engaged with GForce to identify a Quality Assurance consultant. This person will be responsible for the review and processing of manufacturing Deviations and laboratory OOS and review of manufacturing and laboratory-related Change Controls within the established QMS system. This role will also be responsible for the approval of Certificates of Analysis, manufacturing batch record review, and product disposition.

Duties / Expectations of Role

• Support QA activities for early-phase (preclinical through clinical phase I/II) clinical development programs
• Ensure compliance with GMP in addition to internal policies and procedures
• Provide strategic QA input to cross functional teams, including Clinical, Regulatory Affairs, Analytical Development and CMC
• Serve as QA representative on development project teams and advise on risk mitigation strategies
• Contribute to the authoring and review of SOPs, protocols, reports and specifications
• Process and approve change controls, OOS and deviations within the QMS system
• Review and approve CMO’s master batch records, analytical documents and validation protocols
• Review executed batch records and disposition batches per internal policies and procedures
• Participate in CMO and internal operations meetings

Mandatory Requirements

• Bachelor’s or advanced degree in life science or a related field
• 7-10 years of experience in Quality Assurance within the pharmaceutical / Biotechnology industry
• Experience in early-phase clinical development and a sound understanding of the drug development life cycle
• Strong knowledge of deviation and change control systems.
• Laboratory background with method methods
• Experience with investigations using root cause analysis, CAPA and CAPA effectiveness
• ASQ Certification Preferred

Term & Start

• 6-month contract with intent to convert to FTE
• Hybrid 3 days a week or remote depending on location

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Contract

Job function

• Job function

  Science, Quality Assurance, and Research

• Industries

  Pharmaceutical Manufacturing, Biotechnology Research, and Research Services

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Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

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