Quality Control Scientist I
About The Position
Astellas is a global life sciences company developing transformative therapies in areas including oncology, ophthalmology, urology, immunology, and women's health. The Quality Control Scientist I supports the AIRM MA-TC GMP Environmental Monitoring (EM) program and microbial testing. The role includes reviewing EM and laboratory test results, technical writing and projects, and training and coaching team members. The position supports GMP operations and is scheduled Monday to Friday, first shift, 8 a.m. to 5 p.m. This is an on-site role in a cGMP-regulated manufacturing facility. The position frequently involves extended periods of sitting and standing, use of hands, bending, stooping, and lifting up to 35 pounds. It requires gowning in the cleanroom for extended periods and wearing gloves and a mask to prevent exposure to biohazards and viruses.
Requirements
- B.S. degree in Biology or Microbiology with 8 years of relevant industry experience in a QC laboratory, or an M.S. degree with 4 years of relevant industry experience in a QC laboratory.
- Demonstrated experience with aseptic techniques and common microbiological testing.
- Good documentation and data-organization skills, attention to detail, and focus on quality and timely batch release.
- Ability to complete assigned work in a timely manner in a fast-paced team environment.
- Strong interpersonal and collaboration skills, including contributing to a supportive and positive multidisciplinary team environment.
- Ability to work the scheduled day shift, Monday to Friday, 8 a.m. to 5 p.m.; flexibility may be required to support GMP operations.
- Ability to observe and adhere to laboratory safety standards and procedures.
Nice To Haves
- Prior experience in a QC environment.
- Knowledge of cGMPs and regulatory requirements pertaining to the biotechnology and pharmaceutical industries.
- Model Astellas' core values—Be Bold, Care Deeply, and getting stuff done—while promoting team culture and compliance.
Responsibilities
- Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
- Review environmental monitoring and laboratory test results and documents for product testing, EM, and trend reports.
- Oversee trending and reporting of environmental data.
- Serve as a subject matter expert and trainer for microbial testing, including media release and product testing for Gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
- Serve as a subject matter expert for EM and laboratory assays; support assay qualification, instrument troubleshooting, and procedure and report writing.
- Receive manufacturing samples for QC analysis, ship samples to contract laboratories for testing, and review data for lot disposition.
- Author non-conformance, deviation, and out-of-specification investigations and work with the team to identify root causes and corrective actions.
- Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
- Author and approve SOPs, protocols, reports, data summaries, and quality systems internally and at contract laboratories and CMOs.
- Support QC equipment validation, maintenance, and calibration, as well as QC laboratory scheduling and maintenance.
- Own and participate in technical projects and documents for process improvement and implementation; work with rapid assays including CCIT, Mycoplasma, and Sterility.
- Represent QC in cross-functional meetings and provide support and feedback on microbial quality and facility contamination control.
- Collaboratively develop and maintain the facility's contamination control strategy.
- Support and mentor routine work and coach team members on testing, technical documents, and projects.
- Observe and adhere to laboratory safety standards and procedures.
Benefits
- Medical, dental, and vision insurance.
- Paid time off options, including vacation and sick time, plus national holidays and year-end shutdown.
- 401(k) match and annual company contribution.
- Company-paid life insurance.
- Annual corporate bonus and quarterly sales incentive for eligible positions.
- Long-term incentive plan for eligible positions.
- Company fleet vehicle for eligible positions.
- Referral bonus program.
- Global collaboration with colleagues dedicated to improving patients' lives.
- Opportunity to contribute to therapies that reach patients worldwide.
- Opportunity to participate in scientific innovation and shape the future of healthcare.
- Supportive environment that values contributions, champions development, and empowers employees to pursue their passions.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
