Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)

Cedent Consulting Inc.; Cambridge (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading consulting company in biopharmaceuticals is seeking a Compliance Specialist in Cambridge, MA. This role involves supporting manufacturing execution and quality systems while driving process improvements. Candidates should possess a BA/BS in a scientific discipline and 2-5 years of relevant experience in a manufacturing environment. Responsibilities include managing change controls, leading investigations, and collaborating with cross-functional teams.

Qualifications

• 2-5 years in a biopharmaceutical manufacturing environment.
• Knowledge of Current Good Manufacturing Practices.
• Willingness to work weekends and rotating holidays.

Responsibilities

• Coordinate and complete manufacturing projects.
• Lead investigations and troubleshoot deviation reports.
• Implement corrective actions and validation protocols.

Skills

Quality Systems

Problem Solving

Collaboration

Communication

Organizational Skills

Education

BA/BS in a scientific discipline

Tools

OpCenter

ERP

EBR

Veeva

Microsoft Office

Job description

Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)

The Compliance Specialist supports projects, manufacturing execution, computer systems (GP, EBR, OpCenter APS), quality systems (deviations, change controls, CAPAs), and implements lean/continuous improvement initiatives within the Manufacturing department.

Schedule:
This role requires on-site work five days per week, emphasizing teamwork and collaboration.

Position Scope:

• Coordinate and ensure successful completion of manufacturing projects.
• Initiate, revise, and approve manufacturing procedures, serving as a document owner where applicable.
• Lead investigations and troubleshoot deviation reports.
• Manage Change Control Records or assist in manufacturing change processes impacting the process.
• Assess manufacturing performance through observation and data review to implement process improvements.
• Assist in creating training materials and providing technical training on manufacturing processes.
• Implement corrective actions and assist with validation protocols.
• Participate in regulatory inspections and address any corrective actions required.
• Support tech transfer activities, including documentation, training, and system modifications.
• Lead or participate in initiatives like Lean tools or process improvements.
• Collaborate with cross-functional teams across QA, QC, Engineering, Validation, Material Management, and Project Management.

Qualifications:

• BA/BS in a scientific discipline or equivalent experience.
• 2-5 years in a biopharmaceutical manufacturing environment.
• Experience with computer systems such as OpCenter, ERP, EBR, and Veeva.
• Knowledge of biopharmaceutical equipment and manufacturing systems.
• Understanding of Current Good Manufacturing Practices and regulatory requirements.
• Excellent communication skills, both written and verbal.
• Strong organizational and planning skills, with the ability to work collaboratively.
• Proficiency in Microsoft Office.
• Willingness to work one weekend day, evenings, and rotating holidays as required.
• Ability to gown and gain access to manufacturing areas.

Preferred Qualifications:

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