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Biologics Manufacturing (AM) Jobs

Smithfield, Rhode Island

<p> Biologics Manufacturing (AM) AP7115446</p><p> Smithfield, RI 02917</p><p> 7 Month Contract</p><p> *** No Subcontractors ***</p><p> Skills/Qualifications:</p><p> Must have in-depth knowledge of biologics manufacturing operations or clean utilities operations Must be able to translate bio-tech processing into documentation such as batch records and SOPs Knowledgeable of current Good Manufacturing Practices (GMPs) and regulatory requirements.</p><p> Must possess strong verbal and written communication skills Recommended 3+ years experience in a GMP biotech/pharmaceutical manufacturing environment or have a significant level of transferrable work experience to ensure the immediate support of the manufacturing team</p><p> Duties:</p><p> The Operations Specialist will have experience working with biologics manufacturing and/or facilities GMP equipment. For example (ultrafiltration, centrifuge, autoclave, parts washer, WFI, clean steam). The specialist will have strong writing skills to develop SOPs, batch records and training documentation based on facility drawings and end user input.</p><p> The position requires accountability for project deliverables for GMP process equipment and clean utilities while working with Quality Assurance, Quality Control, Technical Services, Engineering, Facilities/Maintenance, Automation, Logistics, Training, Validation, and CMC/Regulatory. Success will be measured by (1) compliance with all environmental, safety, and GMP requirements and metrics (including deviations and Right First Time execution), (2) ability to meet all project timelines and goals.</p><p> Principal Responsibilities:</p><p> Taking direction from MFG or Facilities system owners; author new and revised SOPs, training documentation and master batch records in support of theSite Master Plan Project. Update project team on deliverable status. Fill in progress trackers. Communicate progress with system owners Initiate, revise, and approve MFG and Facilities procedures. Ensure all procedures reflect project requirements. Assess process performance by observation of floor operations and review of performance data with the objective of implementing process improvement solutions</p><p> Education: BA/BS in a technical or scientific discipline is required.</p>

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