Massachusetts Jobs

Quality Assurance Specialist

Bedford, MA

Job Type: Contract

Recruiter: Christie Spencer (https://digitalprospectors.com/our-team/christie-spencer)

Phone: 603.609.7082

Position: Quality Assurance Specialist (Warehouse Operations)

Location: Bedford, MA (Onsite)

Length: 12 months

Covid Requirements: N/A

Job Description:

Our client is seeking a Quality Assurance Specialist to provide QA support of the warehouse and supply chain processes at the new gene therapy manufacturing facility. The Quality Assurance Specialist will provide critical quality oversight of the incoming material process to ensure compliant receipt, inspection, and release of materials used in cGMP manufacturing operations during the qualification phase. The Quality Assurance Specialist will provide quality floor support of the warehouse and cryogenic facilities including, leading the effective resolution of deviations and nonconformance's associated with materials, suppliers, and storage.

This role will partner with Supply Chain, Warehouse, Manufacturing, Engineering, Validation, IT (ERP), and Quality Control functions to execute and continuously improve operating procedures that interface with the ERP system such as label inspection, container and closure inspection, retain management and disposition of starting and raw materials. The Quality Assurance Specialist will be a key contributor of the Material Review Board (MRB) and will support quality decisions related to material movement, supplier management, and multi-product controls at the site. As new products are introduced, the Manager/Senior Associate, Quality Assurance Specialist (Warehouse Operations) will work cross-functionally to onboard GMP materials through participation in risk assessments, Material Review Board, generation of specifications, master data review, and supplier qualification activities.

Essential Duties and Responsibilities (but not limited to):

• Collaborate in the design and implementation of effective quality assurance systems for material inspection, disposition, and movement at the new gene therapy manufacturing facility.

• Support supplier quality management and multi-product material controls at the site.

• Employ Quality Risk Management (QRM) to evaluate new challenges impacting the warehouse and/or supply chain.

• Perform formal risk assessments as applicable.

• Responsible for writing, revising, reviewing, and/or approving documents associated with GMP materials such as SOPs, work instructions, and protocols.

• Work cross-functionally to investigate and resolve deviations.

• Responsible for reviewing and approving ERP processes (metadata) to ensure seamless integration and accuracy with manufacturing operations and batch disposition.

• Conduct quality assurance assessments required for the onboarding, use and release, management, and qualification of GMP materials.

• Execute quality assurance review and approval of master data in the ERP system.

• Verify chain of custody and complete final release of GMP raw materials.

• Perform quality assurance assessments of non-conforming materials and monitor quality metrics associated with the material and supplier.

• Identify and implement continuous improvement activities to eliminate waste and increase the efficiency and effectiveness of quality oversight.

Qualifications:

• Bachelor’s degree in a Scientific or Engineering field.

• 5+ years of experience in a GMP regulated industry (preferably biopharmaceutical, biotechnology, cell, or gene therapy industries) with roles in Supply Chain, Manufacturing, or Quality (quality experience preferred).

• Experience working at a biologic or advanced therapy pharmaceutical manufacturing site.

• Strong knowledge of domestic and international GMP regulations and their application in the manufacture of biologics, cell, or gene therapy products.

• Demonstrated ability to communicate technical information or complex situations to supervisor or area management in a concise and clear manner.

• Ability to travel to other Boston-area locations for larger team meetings (travel may be required up to 5%).

POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Make this your next career move as one of our many long-term contractors or employees!

• Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.

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• 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 ‘Employee’s Choice - Best Places to Work’ by Glassdoor.

• Voted ‘Best Staffing Firm to Temp For’ five times by Staffing Industry Analysts as well as a ‘Best Company to Work For’ by Forbes, Fortune and Inc. magazine.

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