Quality Control Analyst
About the role
Astellas is a global life sciences company dedicated to transforming innovative science into value for patients. We focus on diseases such as oncology, ophthalmology, urology, immunology, and women's health. Our commitment is to develop new healthcare solutions for conditions with significant unmet medical needs. If you're driven to make a real difference in patients' lives, we welcome passionate individuals who thrive in dynamic environments, embrace new ideas, and take intelligent risks. We seek people who act with unwavering integrity and are deeply committed to making a tangible impact.
Responsibilities
- Perform and review laboratory testing, including viable air, non-viable particulates, and surface viable samples.
- QC testing of samples for bioburden, microbial identification, growth promotion, and endotoxin analysis.
- Receive and analyze manufacturing samples for QC purposes, ship samples to contract laboratories, and review data for lot disposition.
- Read and review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
- Understand and adhere to aseptic behavior, good laboratory and manufacturing practices, and documentation.
- Help with assay/instrument qualification, troubleshooting, and procedure/report writing.
- Author/update laboratory procedures, protocols, and EM data trend reports.
- Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
- Initiate investigations and work with the team to find root causes and corrective actions.
- Perform QC lab support activities like lab setup, housekeeping, instrumentation maintenance, and coordinate instrument calibration.
Requirements
- Bachelor’s degree in Biology or Microbiology with 3+ years of relevant industry experience, or Master’s degree with 0-2 years of relevant industry experience in a QC lab.
- Demonstrated experience of aseptic techniques and common microbiological testing.
- Ability to gown into cleanrooms to perform EM testing.
- Good documentation, data organization, detail-oriented, and willingness to learn.
- Capable of observing and adhering to lab safety standards and procedures.
- Successfully performs routine work independently with minimal instructions.
- Excellence in a fast-paced team environment and timely completion of assigned work.
- Strong interpersonal skills, highly collaborative within a multi-disciplinary team, and contributes to a supportive and positive work environment.
Qualifications
- Bachelor’s degree in Biology or Microbiology with 3+ years of relevant industry experience, or Master’s degree with 0-2 years of relevant industry experience in a QC lab.
- Demonstrated experience of aseptic techniques and common microbiological testing.
- Ability to gown into cleanrooms to perform EM testing.
- Good documentation, data organization, detail-oriented, and willingness to learn.
- Capable of observing and adhering to lab safety standards and procedures.
- Successfully performs routine work independently with minimal instructions.
- Excellence in a fast-paced team environment and timely completion of assigned work.
- Strong interpersonal skills, highly collaborative within a multi-disciplinary team, and contributes to a supportive and positive work environment.
Skills
- Experience in QC environments.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
- Model our core values: Be Bold, Care Deeply, get stuff done, and promote the team culture and compliance.
Benefits
- Medical, Dental, and Vision Insurance
- Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down
- 401(k) match and annual company contribution
- Long Term Incentive Plan for eligible positions
- Company paid life insurance
- Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
- Company fleet vehicle for eligible positions
- Referral bonus program
Pay
$69,790 - $99,700 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience, and organizational equity considerations.)
Schedule
This role is scheduled for Monday to Friday Day shift supporting GMP operations. Flexibility may be required to support weekend GMP Operations.