Quality Assurance Specialist

2 weeks ago

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

CSBio is a leading peptide contract manufacturing organization that specializes in the production of high-quality compounds for research and pharmaceutical applications. Established in 1993, we have consistently focused on delivering excellence in cGMP production. Our facilities are equipped with state-of-the-art technology, ensuring compliance with the highest industry 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 testing methodologies.
  • Develop and approve operational procedures, work instructions, and policy documents to enhance CSBio's Quality Management Systems.
  • Facilitate and respond to client audits and regulatory inspections, ensuring compliance and transparency.
  • Provide quality oversight and validation approval for documentation related to equipment, processes, facilities, and software.
  • Review batch records and analytical data to support the release of Active Pharmaceutical Ingredients (API), raw materials, and product labeling.
  • Lead initiatives aimed at continuous improvement to enhance quality and operational efficiency.
  • Conduct qualification assessments of suppliers, contract laboratories, and service providers.

Essential Competencies:

  • Problem Solving: Effectively identifies and resolves issues; analyzes information skillfully; develops alternative solutions; collaborates well in group settings.
  • Team Collaboration: Balances individual and team responsibilities; demonstrates openness to diverse perspectives; encourages feedback and supports collective success.
  • Organizational Commitment: Adheres to policies and procedures; completes tasks accurately and punctually; aligns with organizational goals and values.
  • Motivation: Sets ambitious goals and demonstrates perseverance; measures performance against high standards.
  • Adaptability: Adjusts to changes in the work environment; manages competing priorities; modifies approaches to suit varying situations.

Qualifications:

  • Bachelor's Degree in Life Sciences, Chemistry, or a related discipline.
  • Over 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 thorough understanding of ICH and FDA regulations.
  • Proficient in problem-solving and quality enhancement methodologies.
  • Ability to work collaboratively in a fast-paced, cross-functional team environment.

Employee Benefits:

  • Comprehensive medical, dental, and vision insurance plans.
  • Basic life insurance coverage provided by the company.
  • Disability insurance options available.
  • 401k plan with a generous employer match.
  • Paid time off policy.
  • Company-sponsored holidays and social events.
  • Incentives for carpooling and clean air vehicle usage.
  • Employee recognition and rewards program.

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