Sr. QC Associate, Microbiology

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!

Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.

Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.

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

Purpose:
The Sr. QC Associate performs all tasks necessary for the manufacturing operations as it relates to Quality Control. Includes but is not limited to: Equipment and Method Validation, Trending and Data analysis, Product Attribute Testing, Environmental Monitoring, Water Sampling and testing, Raw Materials and all related Documentation in accordance with GDP/GMP guidelines.

Essential Job Responsibilities:

• Reviews, edits, completes, and/or revises data capture forms, logbooks, reports and SOPs in accordance with cGMP standards and compliant with written procedure.
• Leads alert/action limit excursion investigations, OOS internal and external investigations and implements and oversees CAPAs.
• Performs routine EM and water sampling and testing as needed.
• Monitor and trend EM and water data and update management on environmental trends.
• Support regulatory PAI and GMP inspections in a global environment.
• Interact with vendors/contract laboratories to ensure quality of external testing procedures.
• Assist with the design, development and implementation of quality control microbiology training programs and training other employees.
• Participates in equipment start-up, commissioning, and validation activities as needed
• Leads/Assists with the implementation/validation of onsite testing such as (sterility, endotoxin and microbial ID).
• Ensures equipment operational readiness and assist with troubleshooting in case of equipment failure.
• Ensures methods compliant with GMP regulations and performs troubleshooting as needed.
• Participates in defining robust process parameters during routine manufacturing campaigns.
• Works to optimize, trend, and report manufacturing process operational parameters during routine manufacturing campaigns.
• Ensures all tasks are performed in a manner consistent with safety standards.
• Represents QC Microbiology in meetings, conferences, workshops as required.

Qualifications:
Required:

• BS degree with 5+ or MS with 2+ laboratory experience
• Knowledge of GMP, SOP's and quality control process.
• Proficient in MS Word, Excel, Power Point and other applications.
• Strong written and verbal communication skills.
• Ability/Flexibility to work weekends is required.

Preferred:

• Bachelor's or Master's degree in Microbiology, Biochemistry or related discipline with 2-4 years of relevant biotech or pharmaceutical industry experience.
• Individuals experienced with implementing equipment/method validation preferred.
• QC Microbiology experience performing and validating endotoxin assay and sterility testing in the biotech and/or pharmaceutical industry.
• Excellent knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance.
• Ability to lead/perform tasks with minimal supervision.

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
• Referral bonus program

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Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled