QC Microbiology Associate I

Astellas Pharma • Westborough, MA

5d • $59,640 - $85,200 • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Familiarity with cGMP regulations and Good Documentation Practices.
• Experience with microbiological testing, environmental monitoring, or cleanroom operations

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.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level