Astellas Pharma Sr. Quality Control Specialist (Microbiology) in Marlborough, Massachusetts
The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma 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.
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
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 Marlborough, Massachusetts.
Purpose & Scope:
The Sr. Quality Control Specialist 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, 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 testing as needed.
- Monitor and trend EM 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.
- Bachelor's or Master's degree in Microbiology, Biochemistry or related discipline with 2-4 years of relevant biotech or pharmaceutical industry 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.
- 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.
- Implementing a microbial identification program using Vitek.
- Excellent knowledge of GMP, ICH, USP, JP, EU and global compendial regulations and guidance.
- Ability to lead/perform tasks with minimal supervision.
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Category Quality Assurance/Quality Control