Specialist, Manufacturing Compliance
- Type Contract
- Salary competitive
- Location Austin, Texas
- Sectors Pharma & Biotech, Medical Devices, Engineering
Supports production floor compliance activities including, but not limited to, batch record and facility/equipment log book review. Each batch has been produced and tested/checked in compliance with the manufacturing batch record requirements, including the final manufacturing signature approval. In addition, this individual will evaluate area processes and identify opportunities for continuous improvement from a compliance/quality perspective. Major Duties and Responsibilities: Provides a real time, production-floor audit, of process manufacturing batch records. Audits each page of the batch record, identifies that appropriate equipment and commodities are being used for the respective application, and ensures process steps are documented in timely and accurate manner Identifies discrepancies in batch record audit and escalates to appropriate individuals for investigation and corrective action Responsible for final manufacturing signature on production batch record. Tracks and trends batch record errors, identifies gaps, and provides feedback to business unit staff in an effort to confirm corrective actions and minimize compliance risk
Identifies continuous improvement opportunities through the completion of routine manufacturing audits, log books, safety, gowning room, and other operational disciplines, as defined, in manufacturing SOPs. Confirms compliance gaps, escalates, and helps develop improvement plans. Evaluates opportunities for streamlining the manufacturing process.
Identifies and support the implementation of standard work practices. Responsible for providing process evaluation/analysis, preparing written reports, summaries, and memos, as necessary. Adheres to guidelines, SOPs, and plant policies. Performs other duties, as assigned. Skills/Experience/Education: Associate's Degree is required (Engineering or Science related preferred). 2-3 years prior experience in manufacturing operations, preferably in pharmaceutical, food, or cosmetic industry.
Sthree US is acting as an Employment Business in relation to this vacancy.