Job Information
Astellas Pharma Sr. QC Associate, Microbiology in Westborough, Massachusetts
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