Sr. Quality Specialist, Material Management
Boston, Massachusetts, United States
Job Description
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.
- ssists 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.
- Bachelor's degree in a scientific or allied health field.
- 5 years of relevant industry experience such as materials management, supply chain, quality assurance and/or manufacturing in biotechnology/regulated pharmaceutical environment.
- Knowledge of cGMP's in a pharmaceutical setting.
- bility to collaborate effectively within a team.
- bility 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.
- 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.
- pprove 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.
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