Quality Control Specialist

2 weeks ago

Germantown, Maryland, United States Precigen Full time
Job Title: QC Analyst I/II, Environmental Monitoring

Precigen is a pioneering biopharmaceutical company dedicated to advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in our core therapeutic areas of immuno-oncology, autoimmune disorders, and infectious diseases.

We are seeking a highly motivated and detail-oriented QC Analyst I/II, Environmental Monitoring to join our high-performing team. This role will require performing environmental monitoring sampling, sample incubation, data analysis, and reporting according to quality requirements to support GMP manufacturing. Secondary responsibilities include GMP lot release testing.

Key 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.
  • Investigate environmental monitoring excursions.
  • Track and trend EM data.
  • Develop and revise QC SOPs related to environmental monitoring equipment and procedures.
  • Perform QC testing of raw materials and/or schedule testing through contract testing laboratories.
  • Perform QC lot release testing, including endotoxin, Gram stain, and bioburden testing.
  • Maintain and operate QC laboratory equipment in a cGMP-compliant manner.
  • General maintenance of the laboratory, including ordering and receiving QC materials.
Requirements:
  • Bachelor's Degree in biological science.
  • Minimum of 2 years of environmental monitoring experience in a GMP environment.
  • Knowledge of current Good Manufacturing Practices (cGMPs).
  • Experience with methods and systems used in a biological QC laboratory.
Desired Competencies:
  • Ability to work in a fast-paced company environment and adjust workload based on changing priorities.
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description and perform other responsibilities to support the needs of the department.
  • 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.
  • 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.
  • Ability to think and adapt to a rapidly changing environment and demands.

Precigen (Nasdaq: PGEN) is a dedicated discovery and clinical stage biopharmaceutical company advancing the next generation of gene and cell therapies using precision technology to target the most urgent and intractable diseases in immuno-oncology, autoimmune disorders, and infectious diseases. We invite you to discover more at www.precigen.com.

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