The Environmental Monitoring and Microbiology Scientist, Quality Control is responsible for working both independently and with the team to perform routine and non-routine microbiological testing, microbiology maintenance functions and Environmental functions as deems necessary. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.Job Functions
- Performs responsibilities in compliance to the companys policies, procedures, and federal, state, and local laws.
- Performs duties according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), USP, EU and other global regulatory requirements at all times.
- Communicates effectively with QC personnel, cross-functional teams and management.
- Participate in aseptic process qualifications, such as aseptic gowning and media fill reads.
- Perform environmental and utility monitoring
- Perform QC micobiological testing such as Bioburden, Endotoxin, TOC, Conductivity.
- Perform growth promotion testing of microbiological media.
- Perform mycoplasma testing via PCR.
- Send out samples to contract labs and track results/reports.
- Evaluate environmental/personnel monitoring samples and create NOEs for action levels.
- Assist in the training of laboratory staff.
- Performs general laboratory cleaning/wipe-down.
- Perform routine maintenance of lab equipments.
- Under the guidance of management, support special project work.
- Document laboratory test results on worksheets, forms and logbooks utilizing Good Documentation Practices.
- Maintain lab inventory and order lab supplies and materials.
- Receives and stock test reagents, lab supplies and test media.
- Support continuous improvement projects related to QC
- Author and revise controlled documents such as Standard Operating Procedures and Controlled Forms. Author non-routine Protocols/Validation Plans/ reports in support of projects.
- Assist with investigations and CAPAs associated with Microbiological testing and Environmental Monitoring.
- Support data trending, tracking of results and provide metrics as applicable.
- Perform all other duties as assigned.
Education and Experience:
- Candidate must possess strong technical knowledge and experience in microbiology operations of pharmaceutical industry.
- Solid track record of working experience in microbiological quality control operations to support clinical manufacturing product testing.
- Hands-on experience in environmental monitoring (air, surface, water), method validation and transfers.
- Experience with a wide-variety of software and information systems (e.g. TrackWise, Master Control, and preferably LIMS).
- Ability to manage multiple priorities to achieve department and site objectives.
- Ability to evaluate technical data
- Proven experience in risk mitigation planning and ability to solve complex QC technical problems. Be able to make appropriate judgment and decisions based on available knowledge and data to ensure the safety and success of the manufacturing support and product testing.
- Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills).Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively.
The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.
- Requires Bachelors degree in Microbiology, Molecular Biology, or related discipline and minimum 4 years of experience working in a regulated manufacturing environment.
- Microbiology lab experience & Masters Degree strongly preferred. An equivalent combination of experience/education is acceptable.
- Have a good understanding of USP, EP, JP, and FDA microbiology testing requirements.
- Good knowledge of Microsoft Word and Excel.
- Responds to challenges and additional projects in an understanding, positive, and objective manner.
- Adaptable to dynamic conditions, work practices, and project timelines.
- Ability to multitask, prioritize workload and interpret data accurately.
- Fosters teamwork and promotes an environment that motivates others to achieve our goals.