Job Description
Duties and responsibilities
- Evaluate QC Microbiology activities.
- Responsible for testing and monitoring.
- Participate in the environmental monitoring program and follow related established procedures.
- Oversee the microbiology laboratory.
- Manage the media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.
- Develop study designs, data/statistical analysis, reporting results in both written and oral format (presentation).
- Responsible for QC Micro material, data review, data trending, comparability, qualification/validation, compendial methods, etc.
- Be able to draft Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.
- Responsible for intra-departmental and inter-departmental collaboration and communication within QC, and with Procurement, Manufacturing and Quality Assurance.
- Problem solving and troubleshooting Microbiology assay as necessary.
- Other duties as assigned
Skills and Qualifications
- B.S. or MS 2-4+ yrs. or Ph.D. in relevant field
- Knowledge of ISO regulations specific to GMP cleanrooms and a good understanding of USP, EP guidelines associated with cell and gene therapies/ biologics.
- Knowledge of compendial microbiological safety testing methods and requirements common to the pharmaceutical industry for bioburden & sterility, mycoplasma, endotoxin, etc., and experience with culturing and identifying various microorganisms (bacteria, yeast, fungi) by different methods (stains, PCR, etc.).
- Experience in plating, reading and reporting results, microbial identification, identification of EM excursions, and trending.
- Experience in CAPA and troubleshooting.
- Ability to process large amounts of documentation in a timely and efficient manner.
- Team-oriented, multidisciplinary, and multicultural environment.
- Able to work flexible hours to meet deliverable deadlines.
- Desire to take initiative on department-wide improvement projects and drive them to completion.
- Experience with media and microbe qualification testing in support of EM and/or (Bioburden) sterility testing.
- A detailed understanding of cGMP/GLP regulations as well as excellent cGDP skills to facilitate the completion of all Quality Control activities.
- Familiarity with basic core QC areas including product/material stability, data review, data trending, comparability, qualification/validation, compendial methods, etc.
- Excellent writing skills and experience in drafting Standard Operating Procedures (SOPs), protocols, reports, environmental monitoring excursions, OOS, investigations, etc.
- Understanding/familiarity with relevant FDA, EMA, ICH, USP and EP guidelines and regulations associated with the quality control of biologic/cell therapies in general and the environmental monitoring and operation of cleanrooms, specifically.
- Excellent interpersonal skills and willingness to work interdepartmentally with QC, Manufacturing and Quality Assurance.
- Ability to solve problems and troubleshoot as necessary.
Working conditions
- Must be able to fully gown-up for aseptic environment work.
- Must be able to occasionally work on weekends and holidays.
- In Office
Equipment
- SAS Super 180 Air Sampler
- QuantStudio 5
- MET ONE 3445+
- Microscopy
- Endosafe® PTS™ or MCS™ Instrumentation
Job Tags
Flexible hours,