Operations Manager – Sterile Fill & Finish Job Vacancy in PCI Pharma Services San Diego, CA 92121 – Latest Jobs in San Diego, CA 92121 – updated today

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Company Name : PCI Pharma Services
Location : San Diego, CA 92121
Position : Operations Manager – Sterile Fill & Finish

Job Description : The Manager of Sterile Fill & Finish (SFF) Operations is responsible for managing the operations of the Aseptic Processing Program to maintain sterility assurance of aseptically manufactured sterile drug products at PCI Pharma Services – San Diego, CA. This individual must be able to work independently with little direction to directly lead the activities of the Sterile Fill/Finish (SFF) area. The SFF Ops Manager ensures the sterile filling jobs are executed accurately, with the highest quality, and on time per the Production schedule. The SFF Operations Manager has responsibility for all of the Operations functions in the area including planning, material procurement, machine and facility maintenance, and filling operations. The SFF Ops Manager works with the highest degree of accountability and customer service to ensure client needs are met in a timely manner. The SFF Ops manager will 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 operations excellence 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. The individual will also work directly with members of the Quality team to support various functions associated with overall organizational quality.
1. Manage the Aseptic Processing Program to execute the developed filling schedule and maintain sterility assurance of aseptically manufactured sterile drug products.
2. Establish, Implement and Review Aseptic Processing Program policies and procedures in coordination with SFF QA Manager.
3. Working in conjunction with QA, the Ops Director will support 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.
4. Provide Metrics associated with the various production aspects of the Aseptic Processing Program. Track / Trend / Monitor data to drive improvements through the organization. Review batch performance to ensure SFF jobs are performing to quotes rate and EBITDA targets.
5. Supervise the selection, workflow, training, and development of SFF Ops staff. Provides hands-on training for staff and develops tools necessary to facilitate successful employee onboarding and routine monitoring to ensure training is robust / accurate. Ensure the SFF production team is staffed with qualified and trained personnel to ensure aseptic filling operations are fully executed in accordance with the approved Protocols for each specific job. Effectively manage and develop others to build a high performing production team. Manage team and individual performance according to specific job requirements and expectations. Drive performance accountability for each direct report. Give specific and timely feedback to production employees to ensure training is robust / accurate. Ensure the SFF production team is staffed with qualified and trained personnel to ensure aseptic filling operations are fully executed in accordance with the approved Protocols for each specific job. Effectively manage and develop others to build a high performing production team. Manage team and individual performance according to specific job requirements and expectations. Drive performance accountability for each direct report. Give specific and timely feedback to production employees.
6. Support / Implement Corrective and Preventative Actions, Change Control Actions, or other items which may be attributed to an area of organizational quality.
7. 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.
8. Proficient in Batch Record reviews for conformance to established procedures and critical process parameters. Performs Ops EBR reviews.
9. Collaborates with Quality to manage vendor / supplier relationship for laboratory services.
10. Provide oversight, routine monitoring and validation for disinfectant program associated with the environmental monitoring program.
11. Serve as the primary subject matter expert in Microbiology, aseptic processing and Contamination Control risk assessment and mitigation strategies.
12. Partner with Quality, Warehouse, Project Management, Engineering, and Facilities to resolve issues in a timely fashion.
13. Supports activities of QC personnel engaged in environmental samples collection, processing and data evaluation.
14. Ensures team members maintain compliance with aseptic principles and adhere to all requirements to protect the sterility & integrity of the process and product. Ensures Ops compliance to the Aseptic Gowning and Training Program.
Job Type: Full-time
Pay: $75,009.00 – $138,569.00 per year
Benefits:

401(k)
401(k) matching
Dental insurance
Employee assistance program
Flexible schedule
Flexible spending account
Health insurance
Health savings account
Life insurance
Paid time off
Parental leave
Professional development assistance
Referral program
Retirement plan
Tuition reimbursement
Vision insurance

Schedule:

8 hour shift
Day shift
Monday to Friday

Supplemental Pay:

Bonus pay

Work Location: One location

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Post Tags : , San Diego, CA 92121, jobs in San Diego, CA 92121, Operations Manager – Sterile Fill & Finish jobs in San Diego, CA 92121

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