Nitto Avecia Pharma Services in Irvine, CA is looking for an experienced Microbiology Supervisor to supervise and contribute to the daily operations of the aseptic Microbiology department. If you have experience in Microbiological standards and methodologies in a CMO or CRO organization and are ready to make a move to a highly respected company in the pharmaceutical industry, this is the opportunity for you.
The Microbiology Supervisor position offers a competitive salary with excellent benefits, including medical, dental, and vision that are available on the first of the month following the first day of employment.What you will be doing:
As the Microbiology Supervisor, you will supervise a team of analysts simultaneously handling microbiology samples and assigning tasks, checking work at frequent intervals, and maintaining schedules based upon directives from senior management. You may become actively involved with hands on work, as required, to meet schedules and resolve problems.
Provide senior level expertise to junior level staff on day-to-day Microbiology EM operations supporting aseptic manufacturing as well as identify or troubleshoot issues that may affect laboratory or facility monitoring systems or processes.
Review all EM data generated and draft EM trend reports, monthly and quarterly EM reports for management review.
Support, train and qualify all EM technicians, analyst and MFG associates.
Provide technical support in the maintenance of monitoring systems and instrumentation.
Schedule and maintain communication with manufacturing, maintenance, engineering and validations in order to complete all required environmental and utility monitoring per internal procedural requirements with minimal impact to interdepartmental schedules.
Represent department in operational meetings and regulatory audits.
Prepare, approve and/or read and understand test methodologies, study protocols, reports and Standard Operating Procedures in order to review or execute testing in compliance with necessary cGMP policies and procedures. Record/review data in controlled notebooks, data sheets, and electronic systems (i.e. LIMS, etc.) in accordance with cGMP requirements.
Notify supervisor of any discrepancy in laboratory testing or general laboratory operations. In case of any observed discrepancies, initiate and follow through with the required quality exception documentation as needed.
Inventory management for the Micro group to support manufacturing work as well as in lab testing.
Support the development and growth of the department by performing advanced level duties, like conducting independent research to collect necessary information from available literature, performing complex analyses and critically analyzing data with minimal guidance, training and mentoring less experienced staff with regards to best laboratory practices, techniques, and troubleshooting method and equipment related issues.
Make recommendations to management with regards to potential business opportunities and/or process improvements.
Provide feedback to employee and management regarding noteworthy employee performance, make recommendations for employee coaching and counseling and advancement where applicable.
Mentor, motivate and challenge to drive high performance and develop team members, encouraging them to reach their full potential.
Oversee workplace cleanliness by implementing, managing and monitoring the 5S method of organization.
Promote a culture of safety, whereby all accidents are preventable, and support site safety initiatives.
Qualifications - Experience and Education:
Knowledge, Skills, and Abilities:
- A minimum of 4 years, 6+ years preferred, Pharma MFG EM and USP testing related work experience.
- Bachelor's degree or equivalent in scientific discipline required.
- Advanced knowledge of aseptic manufacturing regulations, aseptic technique, clean room behaviors, and environmental monitoring operations.
- Developing knowledge of cGMP regulations, and FDA and ICH guidelines as they pertain to aseptic manufacturing operations.
- Advanced knowledge of microbiological practices, procedures, and common analyses, such as Bioburden, Microbial Limits (preparatory & screening), Sterility, Endotoxin (Gel-Clot & Kinetic Chromogenic methods), validation - Inhibition/Enhancement Sterility Test Method Validation (Bacteriostasis/Fungistasis), Preservative Efficacy Testing, and Environmental Monitoring.
- Strong comprehension of USP, Pharm. Eur. and other compendial methods and procedures.
- Sound understanding of how to use LIMS and electronic documentation systems (i.e. Smart Solve, Smart Sheets, 10000 feet).
- Demonstrated problem-solving /decision-making skills with the ability to prepare contingency plans and future strategies proactively. Strong Organizational skills and ability plan ahead an prioritize.
- Strong interpersonal skills. Must be able to express oral and written communication in a clear and concise manner and effectively present information and respond to questions from managers, customers and employees.
- Strong project management skills with demonstrated ability to take programs from concept to execution and manage all stages.
- Ability to work on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors, exercising judgment within defined procedures and practices to determine appropriate action.
- Ability to manage effectively, setting clear expectations, establishing accountability, monitoring progress and outcomes.
- Ability to work effectively under pressure in a rapidly changing environment.
- Ability to work effectively and diplomatically in resolving conflicts.