Compliance Specialist, Cell Therapy Manufacturing; Cambridge, MA

Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)

The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, E , OpCenter APS), quality systems (deviations, change controls, CAPAs) and implementation of lean/continuous improvement initiatives within the Manufacturing department.

Schedule: As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site.

Position Scope:

• Coordinate and ensure successful completion of manufacturing projects.
• Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner where applicable.
• Lead investigations and provide troubleshooting for deviation reports.
• Own Change Control Records or assist manufacturing change owner for changes impacting the process.
• Assess process manufacturing performance by observation of the floor operations and review of performance data with the objective of implementing process improvement solutions.
• Assist in generation of training materials and may assist in providing training on technical aspects of the manufacturing process.
• Responsible for implementation of corrective actions.
• Assist with the execution of validation protocols.
• May participate in regulatory inspections and/or the implementation of corrective actions arising from inspections.
• Participate in tech transfer activities; assess documentation, materials, training, procedures and systems modifications.
• Lead or participate on the assessment or implementation of special initiatives, including Lean tools or process improvements.
• Represent Manufacturing on cross‑functional teams. Collaborate with other departments including QA, QC, Engineering, Validation, Material Management and Project Management.

Qualifications:

• BA/BS in a scientific discipline or equivalent experience preferred.
• 2-5 years of experience in a biopharmaceutical manufacturing environment.
• Familiarity with computer systems such as OpCenter, ERP, E  and Veeva.
• Must be familiar with biopharmaceutical equipment and manufacturing systems.
• Knowledgeable about Current Good Manufacturing Practices and regulatory requirements.
• Excellent communication skills, written and verbal.
• Organizational and planning skills and the ability to cooperate with others in a team environment.
• Experience with Microsoft Office.
• Ability to work 1 weekend day, and evenings as required by management.
• Ability to work a rotating holiday coverage schedule.
• Ability to gown and gain entry to manufacturing areas.

Preferred Qualifications:

• Lean Six Sigma Certification or Experience.
• Root Cause Analysis, GEMBA Problem Solving or equivalent certification or experience.
• Experience with Human Error Prevention Programs (HEPP).
• Basic laboratory skills, including working with mammalian cell culture.
• Experience working in an ISO 7 cleanroom environment.