Sr. Quality Specialist, Material Management

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.

Requirements:

• 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.
• 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.

Must Have Experience with the following:

• 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.