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.
