Sr. Quality Assurance Specialist – Operational Quality, External Manufacturing; VCGT

Job Description

Operational Quality Area Manager will provide QA support for manufacturing and analytical laboratory operations for external manufacturing programs s role will review batch data, including batch records, deviations, in-process data, EM data, QC release and stability testing and other quality systems documentation as needed in support of product disposition.
The ideal candidate will have expertise in reviewing batch records, investigations, disposition and dealing with external vendors in a GMP environment.

• Reviews master batch records and provide customer approval for quality tasks for externally manufactured products
• Reviews analytical laboratory testing data including method validation, QC testing and CoA issuance with providing customer approval for externally manufactured products
• Performs final review of executed batch and/or critical systems documentation including certificate of analysis / certificate of conformance and determines acceptability by using standard operating procedure
• Ensures presence and acceptability of all required documentation prior to the release of the product and/or system
• Assists with analytical investigations, deviations, and change controls for external programs
• Supports the day-to-day management of the batch release process
• Communicates proactively with internal and external partners and management
• Assists in the maintenance and archival of document management such that documents are readily available and easily retrievable
• Assists with metrics and data reporting pertaining to program reporting
• Escalates critical and major findings to Quality management
• Collaborate with external vendors supporting the review of external GMP documentation for product disposition

• Bachelor’s degree in a scientific or allied health field with 5-7 years of relevant work experience, or relevant comparable background
• Knowledge of cGMP's in a pharmaceutical setting
• Experience providing QA support and oversight of GMP manufacturing and GMP laboratory operations with external vendors
• Experience working with external vendors on reviewing external GMP documentation
• Experience successfully leading event investigations, deviations and change controls
• Experience with network-based applications such as Veeva, LIMS and Oracle Strong attention to detail
• Effective communication skills, both verbal and written
• Ability to work in a fast‑paced environment, manage priorities and maintain timelines for multiple projects

$70-75/hr

No C2C or Third-Party Vendors