Vacancy expired!
- Perform Environmental Monitoring of Grade B-D Cleanrooms, including sampling of viable surfaces, viable air and non-viable particulates in a Phase III/Commercial GMP Manufacturing facility.
- Conducts routine sampling and testing of Clean Utilities such as USP water (WFI) and clean steam
- Conducts bioburden testing on prepared buffers/solutions, equipment cleaning samples, in-process and release drug product samples. Ability to isolate and sub-culture microorganisms for identification.
- Provides input on SOP revisions and may assist in the creation and editing of protocols
- Builds credibility within the lab group by performing high quality work
- Works closely with manufacturing and QA to coordinate routine EM, changeover EM, and monitoring to support client campaigns
- Performs Aseptic Process Simulations (media fills) and fill/finish monitoring which includes continuous monitoring of air quality, personnel aseptic technique, and environment integrity
- Compilation and trending of Environmental Monitoring data for reporting purposes
- Report and investigate environmental monitoring excursions.
- Effectively communicates results of own work through discussions and documentation with some input from supervisor
- Flexibility in following unique campaign requirements that may include off-hour and weekend
- Self-starter with the ability to produce results in a fast-paced environment to meet client deadlines under minimal supervision
- Experience with viable and non-viable Environment Monitoring collection instruments.
- Creative individual with outstanding trouble shooting skills
- Concentration of aseptic technique and contamination control
- Streak plating and microbial identification
- Document writing, data interpretation, presentation, statistical analysis and trending a plus
- Escalates problems and factors impacting work performance or completion of assigned tasks to the area supervisor
- Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
- Timeliness and accuracy in completion of projects and documentation (quantity of work)
- Contributions to projects beyond general responsibilities (quality of work)
- Identification of problem areas affecting operations (knowledge/problem solving)
- Offers suggestions for correcting problems and for improving operations
- Understanding of theory, rationale behind tasks performed
- Demonstrated understanding and adherence to Paragon policies, safety procedures and the cGMPs
- PREVIOUS EXPERIENCE:
- B.S. or A.S. in a Life Sciences discipline and 1-4 years of relevant experience working in cGMP cleanrooms
- Experience working in cGMP Quality Control
- Experience with Microsoft Office
- Strong attention to detail
- Familiarity with Good Manufacturing Practices (cGMP's)
- Have the knowledge and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
Vacancy expired!