Manager , Operational Quality, External Manufacturing (VCGT)(Contract) 27669

Atrium Works•Boston, MA

5h•$70 - $75

About The Position

The Operational Quality Area Manager will provide QA support for manufacturing and analytical laboratory operations for external manufacturing programs at VCGT. This 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.

Requirements

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

Responsibilities

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