What are the responsibilities and job description for the QC Analyst II, Environmental Monitoring position at Precigen?
Precigen is clinical stage biopharmaceutical company advancing an exciting pipeline of novel cell and gene therapy products. We are seeking a hard-working QC Analyst II, Environmental Monitoring (EM) who is serious about their discipline and wants to be a key player in a high-performing team. The QC Analyst, EM position will require performing environmental monitoring sampling and incubation, and analyzing and reporting data according to quality requirements to support GMP manufacturing. Secondary responsibilities include GMP lot release testing.
DUTIES AND RESPONSIBILITIES :
DUTIES AND RESPONSIBILITIES :
- Perform environmental monitoring duties including sampling of viable surfaces, viable air and non-viable particulates in a GMP Manufacturing Facility.
- Incubate and culture viable EM samples.
- Perform GMP personnel gowning certifications.
- Report results from environmental monitoring and personnel samples and ship for ID testing, when applicable.
- Report and investigate environmental monitoring excursions.
- Track and trend EM data.
- Write and revise QC SOP’s related to environmental monitoring procedures and equipment.
- Perform QC testing of raw materials and schedule testing through contract testing laboratories.
- Perform QC lot release testing including, but not limited to: Endotoxin, Gram Stain.
- Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
- Perform general laboratory maintenance, including ordering and receiving QC materials.
- Bachelor’s Degree in Biological Science or related discipline.
- Minimum of 2-years environmental monitoring experience in a GMP environment.
- Knowledge in principles and practices of current Good Manufacturing Practices (cGMPs).
- Experience with methods and systems used in a biological QC laboratory.
- Comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities.
- Self-motivated and willing to accept responsibilities outside of initial job description and perform other responsibilities to support the needs of the department, as assigned.
- Positive interpersonal skills.
- Self-organizer, meticulous hands-on habits, keen attention to detail.
- Ability to manage multiple and varied tasks, and prioritize workload.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment.
- Proficient in MS-Word and MS-Excel.
- Strong quantitative and analytical skills.
- Ability to understand and execute on the company’s mission and values.
- Maintain a high degree of ethical standard and trustworthiness.
- Responsive, can-do attitude.
- Deals with conflict in a direct, positive manner.
- Ability to think and adapt to a rapidly changing environment and demands.
