Quality Control Analyst

Astellas Pharma • Westborough, MA

1d • $69,790 - $99,700 • Onsite

About The Position

QC Analyst, 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. This role is scheduled for Monday to Friday Day shift supporting GMP operations.

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 timely fashion.
• Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment.
• This role is scheduled to work during Day shift on Monday to Friday and flexibility may be required to support weekend GMP Operations.

Nice To Haves

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

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 the 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 help in EM data trend reports.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Initiate investigations 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.

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: Mid Level