QC Microbiology Associate I
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. Learn more at Astellas.com.
Are you driven to make a real difference in the lives of patients?
We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.
Purpose & Scope
The QC Microbiology Associate I provides direct support to GMP manufacturing operations through execution of Environmental Monitoring (EM), cleanroom qualification, personnel monitoring, and contamination control activities. This role spends the majority of time in classified cleanroom environments performing routine monitoring and sampling activities to support facility and product quality.
Role and Responsibilities
- ✓Perform routine Environmental Monitoring sampling in Grade A/B/C/D manufacturing environments.
- ✓Collect viable air, non-viable particle, surface, and personnel monitoring samples in accordance with approved procedures.
- ✓Gown into classified cleanroom environments and demonstrate appropriate aseptic behaviors while supporting manufacturing operations.
- ✓Support microbiological testing activities including bioburden, growth promotion, microbial identification, pH, Gram staining, and endotoxin testing.
- ✓Receive, log, label, and process samples in accordance with approved procedures.
- ✓Support laboratory housekeeping, inventory management, and equipment cleaning.
- ✓Follow aseptic technique, cleanroom behavior requirements, laboratory safety procedures, and cGMP regulations.
- ✓Participate in training programs and qualification activities to develop microbiology laboratory competencies.
- ✓Support cleanroom qualification, personnel monitoring, and gowning qualification activities as assigned.
- ✓Escalate environmental excursions, abnormal observations, equipment issues, and documentation errors.
- ✓Participate in continuous improvement initiatives and special projects as assigned
Required Qualifications
- ✓Bachelor's degree in Biology, Microbiology, Biotechnology, or related life science field.
- ✓0-2 years of laboratory experience, preferably in a GMP, biotechnology, pharmaceutical, academic, or clinical laboratory setting.
- ✓Basic knowledge of microbiology laboratory techniques and aseptic practices.
- ✓Strong attention to detail and commitment to data accuracy.
- ✓Ability to follow written procedures and maintain accurate documentation.
- ✓Ability to work both independently and within a team environment.
- ✓Strong communication and organizational skills.
Preferred Qualifications
- ✓Familiarity with cGMP regulations and Good Documentation Practices.
- ✓Experience with microbiological testing, environmental monitoring, or cleanroom operations
Location and Working Environment
- ✓This position is based at AIRM, 9 tech drive -Westboroughand will require on-site work.
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.
Our Organizational Values and Behaviors
Values: Innovation, Integrity and Impact sit at the heart of what we do.
Behaviors: We come together as ‘One Astellas’, working with courage and a sense of urgency. We are outcome focused and consistently take accountability for our personal contribution.
Salary Range
$59,640-$85,200 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations.)
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
#LI-TR1