Quality Consultant

Job Title: Quality Consultant

Location: Bay Area, Hybrid

Duration: 6 Months (with potential extension to 12 months)

Industry: Biotechnology

About the Company:

Our client is a leading biotechnology firm based in the Bay Area. They are seeking a highly experienced Senior QA/QC Specialist to join their dynamic team on a contract basis, with the possibility of extension based on project needs and performance.

Position Overview:

The Senior QA/QC Specialist will be responsible for ensuring the highest quality standards in the company's research, development, and manufacturing processes. This role involves developing, implementing, and maintaining QA/QC protocols, conducting audits, and collaborating closely with various departments to ensure compliance with regulatory requirements.

Key Responsibilities:

• Develop and implement QA/QC strategies, policies, and procedures.
• Oversee the execution of quality assurance and control processes across multiple projects.
• Conduct internal audits and ensure compliance with industry regulations and standards (e.g., GMP, GLP, ISO).
• Collaborate with R&D, manufacturing, and regulatory teams to ensure quality standards are met.
• Lead investigations of non-conformances, root cause analysis, and corrective actions.
• Prepare and present quality reports to senior management.
• Train and mentor junior QA/QC staff on best practices and protocols.
• Stay updated on industry trends and regulatory changes to ensure continuous improvement in QA/QC practices.
• Coordinate with external auditors and regulatory bodies during inspections and audits.

Qualifications:

• Bachelor’s or Master’s degree in a relevant scientific discipline (e.g., Biology, Chemistry, Biochemistry).
• Minimum of 10 years of experience in QA/QC within the biotechnology or pharmaceutical industry.
• Extensive knowledge of regulatory requirements and standards (e.g., FDA, EMA, ISO).
• Proven experience in developing and implementing QA/QC systems and processes.
• Strong analytical and problem-solving skills.
• Excellent communication and interpersonal skills.
• Detail-oriented with a commitment to maintaining high-quality standards.

Preferred Qualifications:

• Experience with biologics or cell and gene therapy.
• Certification in quality management (e.g., ASQ Certified Quality Auditor).
• Project management experience.