QMS Investigator III

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI.  Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.     The position investigates and writes out-of-specifications, deviations, preventive actions, change controls, and other related cGMP documents under minimal supervision. The role supports semi-complex investigations and resolution of issues/potential problems related to Operations/Production. The position writes and edits standard operating procedures (SOPs), change controls, and other related CGMP documents. This position works cross-functionally to coordinate the review, approval and revision of procedures, documents, specifications and forms. The Investigator will work with multiple departments and CGMP disciplines, such as Manufacturing operations, Quality Control, Microbiology, Facilities, and Quality Assurance. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following, but other duties may be assigned. Initiates and/or supports semi-complex investigations and resolution of issues and/or potential problems related to QMS and/or Operations/Production. Coordinates and supports interdisciplinary working teams with recommendations, advice, and action plans for semi-complex investigations, change controls, gap analyses, and risk assessments. Authors and revises change controls and other technical documentation. Manages specific components of large-scale deviations. Tracks and trends documentation and data as specified. Maintains a GLP/CGMP environment and follows SOPs. Adjusts responsibilities and activities to meet client and internal expectations. Follows up on open documents/records to ensure close out of investigations to enable product release in a timely manner. Provides support to internal, client, and regulatory audits as needed. Participates in limited discussions with clients regarding investigations. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices. Embodies PCI Pharma Services cultural values and aligns daily actions with department goals and company culture. Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures. Performs other duties as assigned to support departmental and organizational objectives. Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions…