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Quality Assurance Specialist

2 months ago


Menlo Park, California, United States CSBio Full time
Job Overview

CSBio, a leader in peptide contract manufacturing, has been dedicated to delivering high-quality compounds for research and pharmaceutical sectors. With a commitment to excellence since its inception, CSBio has continually expanded its capabilities, ensuring compliance with stringent cGMP standards.

Key Responsibilities:

  • Evaluate and authorize Master and Executed Batch Production Records (BPRs), Out of Specification (OOS) reports, deviations, Corrective and Preventive Actions (CAPAs), Standard Operating Procedures (SOPs), and analytical methodologies.
  • Draft or endorse procedures, work instructions, and policy documents to enhance CSBio's Quality Management Systems.
  • Facilitate and respond to client audits and regulatory inspections.
  • Provide quality oversight and approval for validation documentation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Supervise batch records and analytical data assessments to support the release of Active Pharmaceutical Ingredients (API), raw materials, and product shipping.
  • Lead initiatives aimed at continuous improvement to enhance quality and operational efficiency.
  • Conduct qualification assessments for suppliers, contract laboratories, and service providers.

Essential Competencies:

  • Problem Solving: Proactively identifies and resolves issues, analyzes information effectively, and develops alternative solutions.
  • Team Collaboration: Balances individual and team responsibilities, remains open to diverse perspectives, and fosters a supportive environment.
  • Organizational Commitment: Adheres to policies and procedures, completing tasks accurately and punctually while supporting organizational goals.
  • Motivation: Sets ambitious goals, demonstrates resilience, and measures performance against high standards.
  • Adaptability: Adjusts to changes in the work environment, manages competing priorities, and effectively handles unexpected challenges.

Qualifications:

  • Bachelor's Degree in Life Sciences, Chemistry, or a related discipline.
  • A minimum of 5 years of experience in Quality Assurance within the pharmaceutical, medical device, or drug manufacturing sectors.
  • Comprehensive knowledge of Good Manufacturing Practices (GMP) and a deep understanding of ICH and FDA regulations.
  • Proficient in problem-solving and quality enhancement methodologies.
  • Ability to collaborate effectively within a cross-functional team in a dynamic environment.

Benefits:

  • Comprehensive medical, dental, and vision insurance options.
  • Basic life insurance coverage provided by the company.
  • Employer-paid disability insurance.
  • 401k plan with a generous matching contribution.
  • Paid time off policy.
  • Company-sponsored holidays and social events.
  • Incentives for carpooling and clean air vehicle usage.
  • Employee recognition programs and team-building activities.