Quality Assurance Specialist

2 weeks ago

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

CSBio is a leading peptide contract manufacturing organization established in 1993, specializing in automated synthesizers for manufacturing and process development, with a strong emphasis on cGMP production. We have expanded our capabilities over the years, enhancing our facilities to meet the needs of research organizations and pharmaceutical companies globally.

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), analytical test methods, and other operational documents.
  • Draft or endorse procedures, work instructions, and policy documents to fortify CSBio's Quality 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) among others.
  • Supervise batch records and analytical data reviews to support the disposition of Active Pharmaceutical Ingredients (API), raw material releases, and product shipping and labeling.
  • Lead initiatives aimed at continuous improvement to enhance quality and efficiency in processes.
  • Conduct qualification assessments of suppliers, contract laboratories, and service providers.

Required Competencies:

  • Problem Solving - Effectively identifies and resolves issues promptly; adept at gathering and analyzing information; develops alternative solutions; collaborates well in group problem-solving scenarios.
  • Team Collaboration - Balances team and individual responsibilities; demonstrates objectivity and openness to diverse perspectives; provides and welcomes constructive feedback; 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 achieves them; demonstrates persistence in overcoming challenges; measures performance against high standards.
  • Adaptability - Adjusts to changes in the work environment; manages competing priorities; modifies approaches to suit varying situations; effectively handles frequent changes and unexpected events.

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 improvement methodologies.
  • Ability to work effectively and collaboratively within a cross-functional team in a dynamic environment.

Employee Benefits:

  • Comprehensive medical, dental, and vision insurance plans.
  • Basic life insurance coverage provided by the company.
  • Disability insurance with standard employer contributions.
  • 401k plan with a generous employer match.
  • Paid time off policy.
  • Company-sponsored holidays and events.
  • Reimbursement programs for carpooling and clean air vehicles.
  • Employee recognition and rewards programs.
  • Opportunities for team-building activities.

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