A well-regarded company focusing on patient therapies is seeking a QC Sr. Microbiologist II to join their team. This is a great opportunity to work for an industry leader!
RESPONSIBILITIES (INCLUDE BUT ARE NOT LIMITED TO):
- Manage the transfer and provide technical oversight of Microbiological methods from Development to QC (validation of methods and tech transfer of methods, including comparability)
- Establish user requirements for purchase, qualification of QC equipment and work with internal and external resources to maintain equipment in an optimal state
- Develop, revise and review SOPs, qualification/validation protocols and reports.
- Conduct investigations regarding out of specifications (OOS) results and address and manage deviations related to micro procedures
- Monitor the GMP systems currently in place to ensure compliance with documented policies
- Review proposed changes to systems, procedures, methods, and submissions to regulatory agencies, as appropriate.
- Gather metric information for use in continuous improvement of areas of responsibility.
- Perform other duties as assigned.
- Bachelor's degree or advanced degree in Microbiology or related discipline
- Six to 8 years’ experience working in a GMP QC Microbiology laboratory, preferably in an aseptic processing facility. A minimum of 3 years’ experience with method and equipment validation within the biotechnology or pharmaceutical industry
- The incumbent will need to have the ability to gown for entry into Aseptic core and supporting areas, and lift approximately 25 lbs.
- The ideal candidate is well versed in various microbiological techniques including rapid release methods (Bac-T, PTS, MCS), and qualifying environmental monitoring processes with reference to cell therapy product
- Strong knowledge of Environmental Monitoring requirements and tests (viable and non-viable), Aseptic Process Validation, Microbial Identification, and other applicable methods to the testing of biopharmaceuticals
- Working knowledge of quality systems and regulatory requirements (21 CRF Part 11/210/211/1271, ISO 14644-1, USP, EP)
- Experience in performing risk assessments
- Strong knowledge of Quality Control processes, GMPs, and Microbiological method validation
- Extensive experience in conducting laboratory and environmental excursion investigations.
- Strong knowledge of Equipment IQ/OQ/PQ/PV
- Proficient in MS Word, Excel, Power Point and other applications
- Ability to communicate and work independently with scientific/technical personnel.
Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [Click Here to Email Your Resumé] or 844-463-6178.