Scientist I, Environmental QC
Location
Rockville, MD | United States
Job description
Rockville, MD, US
Salary Range: $26-36/h
Duration: 1-year W-2 contract with the possibility of FTE conversion
Our company is a biopharmaceutical company focusing on the development of novel cell therapy products for the treatment of advanced solid and hematological malignancies. The Scientist I, Environmental QC is responsible for performing a variety of environmental technical duties in support of the routine operation of Rockville GMP facility for IND and Phase I/II GMP manufacturing. This position will serve as a SME in environmental monitoring, ensuring the regulatory compliance of the GMP facility in collaboration with other functional groups.
Responsibilities and Duties: - Execute daily environmental sampling for dynamic or static environmental monitoring (EM) of cleanrooms.
- Perform incubation, enumeration and gram staining of microbiological organisms.
- Perform growth promotion testing for media release.
- Document and maintain required QC records and logs.
- Trend and analyze EM data.
- Report and participate in the investigation of EM excursions, deviations, out-of-specification results, etc.
- Perform preparation and shipment of EM related samples to external contract testing laboratories when necessary.
- Write technical documents such as reports, change controls, and SOPs.
- Perform visual inspections and release testing on materials as needed.
- Other duties as assigned.
Qualifications and Requirements: - Bachelor of science in a Life Sciences or related discipline.
- 2-5 years of relevant experience working in a Quality Control work environment, preferably in a regulated environment in the pharmaceutical/biotech industry.
- Working knowledge of cGMP regulations.
- Experience working and gowning in a cleanroom environment.
- Aseptic behaviors training
Preferred Qualifications: - Ability to work in a fast-paced environment with little supervision.
- Ability to manage multiple and varied tasks and prioritize workload.
- Flexibility and adaptability to adjust to changing priorities and unforeseen events.
- Attention to details.
- Excellent time management skills.
- Excellent communication and interpersonal skills
- Ability to work evenings and weekends as needed.
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