Specialist, Quality Assurance

Specialist, Quality Assurance

W2 Contract

Pay Rate: $40 - $50 per hour

Location: South San Francisco, CA - Onsite

Job Summary:

This position will provide quality support for our internal quality systems, which govern oversight of external manufacturing and laboratory network (CMO/CLOs). This includes administrative tasks for relevant documentation and electronic systems. This role will also contribute to developing processes and procedures for Quality Assurance.

Duties and Responsibilities:

• Supports users of GMP Quality Management Systems, including those governing document control, deviations, change controls, and CAPAs
• Facilitate document control, managing format, approval, and PDF publishing of controlled documents (e.g. SOPs, Policies, Work Instructions.
• Perform administrative and basic troubleshooting tasks in electronic systems such as Box, MasterControl, and DocuSign.
• Manage access to electronic resources: internal (electronic Quality Management Systems) and external (Pharmacopeia, regulatory documents)
• Engage in improvements and monitoring of electronic quality systems, including oversight of software updates, periodic reviews, and audit trail monitoring.
• Create and maintain metrics and KPIs measuring internal performance (e.g., turnaround time, right first time, quality event rates)
• Writes and implements changes to controlled documents (SOPs, Work Instructions, Specifications, etc.)
• As needed, support oversight and review of documents for external Manufacturing and Quality Control, such as batch records, data, and specifications
• As needed, support quality review and data verification of regulatory dossiers (e.g., IND/IMPD/BLA)
• As needed, support supplier qualification and quality audits, including CMOs/CTLs

Requirements and Qualifications:

• BS in a related scientific discipline
• 2+ years of GMP experience in the Pharmaceutical industry
• Experience with GMP Quality Compliance and related document review/document control
• Excellent working knowledge of Microsoft applications, such as Word, Excel, and PowerPoint
• Experience with electronic Quality Management Systems (e.g., MasterControl, Veeva, Trackwise)
• Current and strong working knowledge of 21 CFR 210-211, Part 11, 610 & 820 cGMP/GLPs; EU cGMP/GLPs; and ICH quality and development guidelines
• Able to travel domestically and internationally

Bayside Solutions, Inc. is not able to sponsor any candidates at this time. Additionally, candidates for this position must qualify as Inc.'s candidate.

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