Cedent

Compensation

Full Description

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.