Astellas is announcing a Senior Associate I, QC Microbiology opportunity at their Astellas Institute of Regenerative Medicine (AIRM) site in Westborough, MA.

Purpose:

AIRM is seeking a highly motivated individual to join us as a Senior QC Microbiology Associate. This position provides Quality Control Microbiology support to all aspects of a GMP environmental monitoring program and microbiology product testing. Looking for strong experience with environmental monitoring and microbiology assays (endotoxin, bioburden, gram staining etc) and microbial identification in a QC environment. Ability/Flexibility to work weekends is required

Essential Job Responsibilities:

• Performing environmental monitoring sampling in manufacturing cleanrooms and lead alert/action limit excursion investigations.

• Organization and completion of assay documentation and entering data into QC database.

• Monitor and trend EM data and update management on environmental trends. Implement corrective action plans when necessary.

• Write, revise and review Standard Operating Procedures and Forms.

• Lab maintenance and updates on equipment calibrations and equipment use logbooks according to cGMP standards.

• Implement endotoxin, bioburden and other microbiology testing at AIRM with required validations.

• Participates in execution of method validations and transfers within and outside of AIRM.

• Interacting with contract laboratories to support sample testing, data analysis and investigations as required.

• Perform and lead RCA, Risk assessments and other GMP investigations

• Participates in facility start-up, commissioning, and validation activities.

• Support regulatory PAI and GMP audits and inspections in a global environment.

• Implement GMP systems in QC and ensure compliance with documented policies.

• Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.

• Perform other lab duties as required.

Required:

• Bachelor’s Degree in Microbiology or related field with 5+ years of Quality Control experience or a Master’s degree in Microbiology or related field with 2+ years of Quality Control experience.

• Knowledge of cGMP, SOP’s and quality control process.

• Experience in the biotech and/or pharmaceutical industry.

• Ability/Flexibility to work weekends is required

Preferred:

• Experience with USP, ICH guidelines and parenteral test methods

• Experience with 21CFR Part 11 Compliance

• Experience with Validation of Analytical Test Methods

Benefits:

• Medical, Dental and Vision Insurance

• Generous Paid Time Off options, including Vacation, Sick time, national holidays, two Heritage Days, and Summer and Winter Breaks

• 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

• Referral bonus program

Category GMP Technical Operations

Astellas is committed to equality of opportunity in all aspects of employment.

EOE including Disability/Protected Veterans