This position responsible for effectively hiring, developing, coaching, counseling, managing and motivating the QC Microbiology staff. They are responsible for the timely and accurate completion of required testing of Environmental Monitoring (EM)/ Clean Utilities, raw materials, in-process and finished products. They assure compliance to GMP and company specifications as well as relevant pharmacopeia compendia. The supervisor identifies areas for continuous improvement and/or implementation of industry best practices and drive implementation in the laboratory. The supervisor keeps laboratory management informed of all departmental activities and product related events.
DUTIES & RESPONSIBILITIES:
- Supervises daily activities of QC Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.
- Hires and oversees the training of QC department personnel. Assures that steps are taken to maintain positive personnel morale and development.
- Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
- Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures.
- Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated. Identifies possible source and corrective action needed and evaluates the impact upon the product.
- Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
- Reviews work performed by department staff for accuracy, completeness and conformance to GDP and product specifications.
- Mentors and develops new department personnel including training in Standard Operating Procedures and On The Job Training (OJT).
- Assures department is equipped with functional, calibrated equipment and necessary supplies.
- Investigates and resolves non-conforming test results by completing thorough Deviation, OOS/OOT, and Laboratory Investigation Reports
- Represents the QC Microbiology department in cross functional teams and internal/external meetings.
- Assumes other duties and responsibilities as assigned.
SKILLS & TECHNICAL EXPERTISE:
- Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
- Experience with viable and non-viable Environment Monitoring collection instruments, techniques and qualifications/validations.
- Creative individual with outstanding trouble shooting skills
- Concentration of experience in implementing aseptic technique and contamination control strategies
- Document writing, data interpretation, presentation, statistical analysis and trending a plus
- Minimum to no supervision required on day-to-day activities and assigned tasks
- Escalates problems and factors impacting work performance or completion of assigned tasks to the area manager along with corrective action plans to resolve identified issues.
MEASUREMENT OF PERFORMANCE:
- Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
- Dependable and can work with minimal supervision on scheduled tasks
- Timeliness and accuracy in completion of projects and documentation (quantity of work)
- Contributions to projects beyond general responsibilities (quality of work)
- Identification of problem areas affecting operations (knowledge/problem solving)
- Implements solutions for correcting problems and for improving operations
- Exercises good judgment in dealing with operational problems
- Advanced understanding of scientific and regulatory theory and rationale behind tasks performed
- Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs
- Ability to succeed in a team-oriented environment under very dynamic conditions
EDUCATION & PREVIOUS EXPERIENCE:
Catalent offers rewarding opportunities to further your career!
- B.S. in a Life Sciences discipline and 5-10 years of relevant and progressive experience working in Quality Control, with 1-2 years of supervisory experience
- Experience working in cGMP cleanrooms
- Experience with Microsoft Office
- Strong attention to detail
- Familiarity with Good Manufacturing Practices (cGMP's) and pharmacopeial compendia
- Have the knowledge and ability to apply advanced scientific and regulatory principles to solve operational, as well as routine quality tasks.
Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
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Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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