Microbiology Supervisor - Pharmaceuticals
|Monroe, North Carolina - United States
$70,000.00 - $75,000.00 - US Dollars - Yearly
WHY IS THIS A GREAT OPPORTUNITY?
Primary responsibilities will be to supervise and coordinate staff performing microbiological testing in support the manufacturing of aseptically processed, terminally sterilized pharmaceutical products and Oral solid dosage products. Provides technical leadership, daily oversight and subject matter expertise as needed to manage the QC microbiology laboratory functions:
- Microbiological testing of Raw-materials, in-process materials and finished products
- Developing and validating microbial test methods for Bioburden, sterility, LPC and endotoxin.
- Reading and reviewing environmental monitoring data.
They will be primary contact for microbiology laboratory, collaborating with personnel outside of the department, facilitating timely and right the first time data management and reporting and assuring testing is completed in support of manufacturing timeline and regulatory standards.
The successful candidate will be comfortable working in a fast paced environment and is flexible, dependable and has the ability to work impudently on assigned tasks.
- Help in Preparation of OpEx and CapEx Budget for the microbiology laboratory.
- Ensure financial prudence in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site.
- Take appropriate steps to reduce wastages and losses in the analysis process and build improved efficiency
- Provides day to day Tactical and logistic support for coordinating execution of activities and/or projects according to timeliness.
- Supervise the testing of in-process, final products and stability samples.
- Review and approves: data, procedures and testing in support to batch release.
- Anticipates and responds to technical problems, coordinate investigations and help develop appropriate solutions, assuring compliance is maintained and timeliness are met.
- Write, Evaluates and approves deviations/ investigations reports.
- Supervises, coaches and develop staff to ensure all activities are performed and documented according to policies, procedures and consistent with cGMP and regulatory requirements. Conduct annual review for all direct reports. Assist in setting performance objectives and development plan.
- Prepare laboratory for internal and external audit. Participate in internal and external audit as required as SME for the department supervised.
- Write, revise and update standard Operating procedure as necessary to ensure compliance.
- To ensure annual maintenance contact renewal (if any), calibration of laboratory instruments. To ensure requalification and calibration of instruments in micro lab as per the schedule.
- Order and maintain inventory of the laboratory reagents, media and supplies as necessary to ensure smooth operations.
- Procurement and qualification of new equipment’s’ requirement in microbiology laboratory.
- Review of change control, incidents, protocols and deviation of other departments related to microbiology.
- Demonstrated subject matter expert in several microbiological disciplines.
- Must be able to wear applicable personnel protective equipment (PPE)
- Responsible for microbiology laboratory personnel.
- Responsible for coordination with Production / R&D/QA/QC for various activities related to microbiology laboratory
- Interact with different departments in case of OOT, OOAC, OOAL and OOS observations related to microbiology
- Train and implement cGMP practices related to microbiology at all the manufacturing and related departments
- Stay current with regulatory and compliance requirement for the microbiology laboratory and update SOP as necessary to ensure compliance.
- Suggest continuous improvement for laboratory procedure and practices.
- Minimum BS/BA in Pharmaceutical Sciences, Chemistry, Biology, Engineering, or equivalent required
- Master degree in microbiology or equivalent, preferred
- 5 to 7 years in the field of Pharmaceutical (formulation facility).
Background of functions of Microbiology. Experience of working with Injectable facility will be an added advantage
- Knowledge of cGMP, Validations and Qualifications, regulatory guidelines, US Pharmacopoeias, Internal auditing, Handling of regulatory Inspections, well acquainted with QMS, well versed with Change control/deviations and market complaint management system.
- Capable to lead team, good communications skills, front runner, GMP trainer.
- Will be an added advantage if the individual has dealt with multiple audits personally
University - Bachelor's Degree/3-4 Year Degree