Compliance Specialist, Cell Therapy Manufacturing (Cambridge, MA)

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Legal & ComplianceCompliance Specialist

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Overview

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Requirements Summary

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, EBR and Veeva.

Technical Tools

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The Compliance Specialist provides support for projects, manufacturing execution, computer systems (GP, EBR, 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, EBR and Veeva.
Must be familiar with biopharmaceutical equipment and manufacturing systems
Knowledgeable of 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.

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