Quality Control Analyst II Microbiology MA-TC

About Astellas

Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology, and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Purpose & Scope

The QC Analyst II, Microbiology will provide support to the AIRM GMP Environmental Monitoring (EM) program and microbial testing. This role is responsible for performing and reviewing laboratory testing, developing and managing technical documents, and conducting training.

Responsibilities

• Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Receive manufacturing samples for QC analysis, ship samples to contract labs testing, 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 follow 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 assist in EM data trend reports.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Initiate Incident reports for OOS results and work with the team to find a root cause and corrective actions.
• Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.

Requirements

• B.S. degree in Biology/Microbiology with 3+ years or MS with 0-2 years of relevant industry experience in a QC lab.
• Demonstrated experience of aseptic techniques and common microbiological testing.
• Must be able to gown into cleanrooms to perform EM testing.
• Good documentation, data organization, detail-oriented, and willingness to learn.
• Must be capable of observing and adhering to lab safety standards and procedures.
• Successfully performs routine work independently with minimal instructions.
• Excels in a fast-paced team environment and completes assigned work in a timely fashion.
• Strong interpersonal skills, highly collaborative within a multi-disciplinary team, and contributes to a supportive and positive work environment.

Preferred Qualifications

• Prior experience in a QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry.
• Model our core values: Be Bold, Care Deeply, and getting stuff done while promoting team culture and Compliance.

Location and Working Environment

• This role frequently requires long hours of sitting, standing, and use of hands, and regular motion to include bending, stooping, and lifting up to 35 lbs.
• Requires gowning inside the cleanroom for extended periods of time.
• Use of gloves and mask is required to prevent exposure to biohazards and viruses.
• This is an on-site role working in a cGMP-regulated manufacturing facility.

What Awaits You at Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Pay

Salary Range: $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 to work during Day shift on Monday to Friday. Flexibility may be required to support GMP Operations.

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
• 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