QA Specialist I - Operations

About the role

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 QA Specialist will work with other departments to ensure the quality of products and compliance to internal procedures and external standards. Primary responsibilities for this role includes Batch Record Review, Lot Disposition, and Quality System review . This position may also be responsible for evaluating deviation incidences and determining which warrant escalation to an investigation, quality review and approval of investigations, and creating and monitoring the associated CAPAs . In this role, the opportunity exists to shape and transform GxP programs by providing QA expertise and guidance to the manufacture of both clinical and commercial products. 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. Perform review of batch documentation for release of internal and external clinical products/commercial products, while ensuring compliance with cGMPs, site SOPs, and regulatory requirements. Prioritize record review in support of business needs including maintaining batch status and communicate release needs throughout the organization Review and approve master batch records for the timely initiation of GxP manufacturing activities Responsible for quality oversight and administration of the deviation/investigation and CAPA programs Review and approve Manufacturing, Quality Control, and other investigations in support of batch release and GMP compliance Provide direction for complex investigations and CAPAs Ensure timely, accurate and complete execution and documentation of quality system events: deviations, NCMRs, GxP investigations and CAPAs Review, develop, and improve quality system procedures, specifications, and test methods Review and approve CAPAs to prevent recurrence of deviations Review and approve Change Control documentation Responsible for tracking investigations and change control for timely completion. Provide status reports, including relevant quality metrics and participates in the management review process Establish collaborative relationships with internal and external customers to ensure all quality and compliance matters and any issues that arise are addressed in an open and timely manner. Monitor, identify and propose quality process and system improvements. Lead improvement projectsand communicate status to management Serve as QA representative to cross functional project teams such as tech transfer, process validation, and process improvement Coordinate change control review meetings Monitor status of change controls and facilitate the approval process Perform risk assessments to comply with internal procedures and external guidelines Provide training on department specific procedures and systems Interface with clients to address any documentation and compliance concerns Initiate, revise, and review controlled cGMP documents including SOPs, Material Specifications, Investigation protocols/reports, validation protocols/reports as applicable Ensures site readiness for regulatory inspections Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. Frequent reading, writing, and verbal communication Must be able to travel between multiple local production facilities Able to translate ideas to actual concepts and processes Proven ability to manage multiple projects (duties) simultaneously Able to work in a highly complex environment with competing demands and priorities Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Cross functional staff, members of management, internal and external clients, members of the Quality organization No managerial responsibilities. This is an individual contributor role. TRAVEL - 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Experience performing RCA, technical writing, and working with