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Quality Manager

Company: PCI Pharma Services
Location: San Diego
Posted on: June 25, 2022

Job Description:

Job DescriptionThe Quality Manager is responsible for Quality Assurance oversight of the Aseptic Processing Program to maintain sterility assurance of aseptically manufactured sterile drug products at PCI Pharma ServicesSan Diego, CA. This individual must be able to work independently with little direction to establish and review policies and procedures and related Aseptic Processing documentation, which may include Standard Operating Procedures, Batch Records and Specifications, Media Fill Summaries, Environmental Monitoring Reports, Deviations and Sterility Failures. Qualified candidates will have experience with Aseptic Processing Validation and Qualification, which includes Equipment and Premises, Cleanroom, Media Fill, Container Closure Integrity, Filter Integrity Testing, and Visual Inspection of filled Vials. Qualified candidates will have worked within an Aseptic Processing Facility and can translate their previous experience into actionable milestones to deliver world class quality for our clients and organization, while meeting all applicable regulatory guidelines and expectations. Qualified candidates will be expected to routinely interact with various members of the Site Leadership Team (SLT), and the individual must be capable of building and maintaining strong relationships with their Operational counterparts. Qualified candidates will also have experience with Aseptic Processing Program deviations, with a strong foundation of Root Cause Analysis Tools and overall report- and SOP-writing. The individual will also work directly with other members of the Quality team to support various functions associated with overall organizational quality. Manage the Aseptic Processing Program Establish, Implement and Review Aseptic Processing Program policies and procedures. Establish and maintain the Aseptic Processing Program's state of compliance with internal requirements and appropriate regulations. Participates in the development of action plans to correct deficiencies and improve quality processes and procedures. Partner with Operations, Warehouse and / or Project Management to resolve issues in a timely fashion. Ability to apply the appropriate level of Quality oversight to ensure processes / procedures are followed. Supervise the selection, workflow, training and development of staff Recommend manufacturing or technology aids to increase speed and efficiency. Provide Metrics associated with the various quality aspects of the Aseptic Processing Program. Track / Trend / Monitor data to drive improvements through the organization. Manage Aseptic Processing Program Non-Conforming Material Reports, Investigations, and Complaints. Ensures department and company goals are met and achieved. Provides hands-on training for staff, and develops tools necessary to facilitate successful employee onboarding and routine monitoring to ensure training is robust / accurate. Support Quality leadership with internal, supplier, regulatory and client audits as the Aseptic Sterility Assurance subject matter expert. Support / Implement Corrective and Preventative Actions, Change Control Actions, or other items which may be attributed to an area of organizational quality. Support the Aseptic Processing Program team to establish cross-department synergies. Provide microbiological and sterility expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill, batch records and reports, validations and specifications. Proficient in Batch Record reviews for conformance to established procedures and critical process parameters. Manage vendor / supplier relationship for laboratory services. Review and approve Batch Records Generate applicable CoCs / CoAs for Sterile Fill Batches by reviewing and approving all pertinent documentation. Provide oversight, routine monitoring and validation for disinfectant program associated with the environmental monitoring program. QA representative for the CCS including presenting current aseptic facility status at the monthly QMR and evaluating pre-approval of Change Controls to ensure sterility assurance is maintained Serve as the primary subject matter expert in Microbiology, aseptic processing and Contamination Control risk assessment and mitigation strategies Oversees the Aseptic Gowning and Training Program. Coordinates activities of QC personnel engaged in environmental samples collection, processing and data evaluation. Ensures team members maintain compliance with aseptic principles, and adhere to all requirements to protect the sterility integrity of the process and product. This position may require extra hours and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.Requirements Bachelor's Degree in a related field and/or 1-5 years related experience and/or training. College Level Mathematical Skills Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs. Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs. Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables. High Standard of Report Writing Highly experienced in Bio pharmaceutical manufacturing and/or aseptic processing working in a GMP environment Experience with regulations (US, EU and other) Advanced experience in Aseptic Processing

Keywords: PCI Pharma Services, San Diego , Quality Manager, Executive , San Diego, California

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