Quality assurance specialist - VCGT

Job Title: Specialist, Quality Assurance Vendor Quality Management - VCGT

Duration: 9 Months possible extension

Location: Boston, MA – fully onsite

Manager Notes

• Oversee Raw Material Inventory Management, Segregation, Storage, and Cycle Count.
• Responsible for review and approve raw material receiving packets. Manage the raw material status in ERP system.
• Approve new material onboarding, qualification protocols, and material qualification reports for VCGT programs.
• Responsible for Vendor Change Notification, Supply Corrective Action Request, Raw Material related deviations, and change controls.
• Provides QA support in the management of SCARs, Change Controls, Vendor Change Notifications, Deviation Investigations.
• Past experience working in established biopharma companies with commercial QA Operation experience.

General/Position Summary

The Senior Operational Area Quality Specialist - Operational Quality, Materials Management will provide QA support

for materials management including the release of incoming raw materials and consumables for internal manufacturing

programs at VCGT. This role will support both commercial and clinical manufacturing operations including review

of incoming raw data, GMP documentation, QC release testing results and other quality systems documentation as needed in support of materials management.

This role will support vendor metrics monitoring, risk mitigations and inspection readiness.

Key Duties & Responsibilities

 Provides QA support overseeing the management of incoming raw materials and consumables for internal manufactured products

 Reviews GMP documentation for incoming raw materials and consumables for internal manufactured products

 Performs final review of executed GMP documentation for the management of materials and determines acceptability by using standard operating procedures.

 Ensures presence and acceptability of all required documentation prior to the release of raw materials and consumables

 Supports the day-to-day management of incoming raw materials and consumables release process

 Provides QA support in the management of SCARs assisting in determining impact to incoming raw materials and consumables as well as supporting vendor investigations

 Maintains and archive files such that documents are readily available and easily retrievable

 Assists department with weekly/monthly/quarterly Quality System data review metrics and reporting pertaining to materials management

 Communicates proactively with internal and external partners as well as with management

 Escalates critical and major findings to Quality management

Required Education Level

 Bachelor's degree in a scientific or allied health field

 Master's degree or relevant comparable background.

Required Experience

Typically requires >5 years of relevant industry experience such as materials management, supply chain, quality

assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.

Required Knowledge/Skills

 Knowledge of cGMP's in a pharmaceutical setting

 Ability to collaborate effectively within a team

 Ability to work in a fast-paced environment, manage priorities and maintain timelines for multiple projects

 Strong attention to detail

 Effective communication skills, both verbal and written.

 Demonstrated success by independently leading cross-functional teams