The QC Environmental Monitoring Specialist will support the Environmental Monitoring Program in the GMP Quality organization. The Environmental Monitoring Specialist will ensure that all aspects of environmental sampling and testing associated with utilities and classified areas are within established alert and action levels.
Duties and Responsibilities:
- Perform routine Environmental Monitoring (EM) of surface, viable and non- viable air, settling plates in Classified areas.
- Perform routine Environmental Monitoring (EM) of surface and room air in Non-classified areas.
- Participate in media fills and product fills which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity.
- Sample and read EM and assess per specifications as appropriate.
- Incubate and enumerate organisms on cultured media
- Perform compressed gas sampling and testing.
- Perform microbial isolation techniques, gram stains, and support microbial identification process.
- Perform sampling and bioburden testing of In-process, Water for Injection (WFI), Purified Water, and City Water samples.
- Perform LAL testing of Water for Injection (WFI), Raw Materials, Final Product using Gel-Clot method.
- Perform Sterility Testing of Release and Stability samples.
- Documentation of results in accordance with current Good Manufacturing Practices (cGMP)
- Coordinate with manufacturing on scheduling of EM sampling
- Support of EM process validation and EM equipment qualifications.
- Responsible for media inventory. Ensure that media used for environmental monitoring passes growth promotion testing prior to use.
- Ability to aseptically gown and work in a sterile work environment.
- Flexibility in following work schedule requirements that may include off-hour and weekend work
- Ability to read, understand and follow SOPs
- Monitoring temperatures of incubators and refrigerators.
- Track and trend EM data including Microbial identification results in support for product release.
- Provide input on SOP revisions and may assist in the creation and editing of protocols
- Participate and write Deviation, OOS, CAPA’s and alert investigation
- Order laboratory supplies as needed.
- Ability to stand for a long period of time
- Ability to lift 25 lbs
- May perform other general laboratory duties as assigned.
- Excellent critical thinking and technical writing skills.
- BS / MS in Chemistry, Biochemistry or related discipline is preferred.
- At least 5 years’ experience in a pharmaceutical industry required.
- A minimum Bachelor’s degree in a scientific discipline is preferred and 1 year of EM experience in a pharmaceutical/biotech industry or
- Associate degree with 3 years EM experience in a pharmaceutical/biotech industry
Position Type/Expected Hours of Work:
This is a full-time on-site position, and hours of business operations are Monday through Friday, 8:30 a.m. to 5 p.m. Must be available to work extended hours as needed to meet deadlines, including weekends from time to time.
Med-Pharmex is an Equal Opportunity Employer. The policy Med-Pharmex is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual’s age, race, color, sex, religion, national origin, disability, protected veteran status, sexual orientation, genetic information, or any other protected category recognized by state and federal laws.