Supervisor, QA NTO
Company: Thermo Fisher Scientific Inc.
Posted on: June 10, 2021
Thermo Fisher Scientific Inc. is the world leader in serving
science, with annual revenue exceeding $25 billion. Our Mission is
to enable our customers to make the world healthier, cleaner and
safer. Whether our customers are accelerating life sciences
research, solving complex analytical challenges, improving patient
diagnostics and therapies or increasing productivity in their
laboratories, we are here to support them. Our global team of more
than 75,000 colleagues delivers an unrivaled combination of
innovative technologies, purchasing convenience and pharmaceutical
services through our industry-leading brands, including Thermo
Scientific, Applied Biosystems, Invitrogen, Fisher Scientific,
Unity Lab Services and Patheon. For more information, please visit
How will you make an impact?
Leads and supervises site Q-Ops related programs and activities
to support the contract manufacturing organization and
manufacturing operations. This role oversees Quality on the Floor,
Batch Record Generation, Review, and Approval. Provides leadership,
strategic thinking, and results focus to reliably meet and/or
exceed the site's production targets while achieving high levels of
quality. This position requires an individual capable of partnering
across the organization to manage a fast-paced production
environment and deliver exceptional service to our clients. Ensures
business, quality and compliance goals are met in full compliance
with all government-issued environmental, health, safety, quality,
and regulatory policies and guidelines.
REPORTING RELATIONSHIPS Supervises: 4-5 direct reports
What will you do?
- Actively participates as a member of the Quality Ops Leadership
Team and partners with the Operations management.
- Supports Manufacturing and Testing Operations during batch
production, ensuring unexpected events are handled compliantly and
in a timely manner.
- Reviews and approves documents including: Manufacturing batch
records in support of product release; Standard Operating
Procedures, Process Validation Protocols and Reports.
- Partners with functional leaders to identify key performance
metrics and develops a plan for routine measurement.
- Manages problems of diverse scope using a high degree of
judgment and risk-based decision making
- Apprises senior management of critical issues.
- Champions process improvement concepts.
- Evaluates the functional strengths and developmental areas in
the Quality organization and focuses on continuous
- Supports a state of continuous inspection readiness
- Promotes Brammer's quality mission, vision and strategy
ADDITIONAL DUTIES AND RESPONSIBILITIES
- Ability to write reports, business correspondence and procedure
- Strong organizational skills; ability to prioritize and manage
through complex processes/projects
- Ability to respond to common inquiries or complaints from
customers, regulatory agencies or members of the business
- Ability to define problems, collect data, establish facts and
draw valid conclusion
How will you get there?
- High school diploma with at least 5-8 years of related
experience in the Quality Unit.
- Preferred BS in Biological Science or related technical
- Extensive exposure to cGMP environment.
- Excellent communication skills
- Ability to multitask, strategically and tactically
- Excellent knowledge of FDA and EMA regulatory requirements
applicable to biologics or pharmaceuticals.
- Ability to apply GMP regulations and international guidelines
to all aspects of the position
- Ability to function in a rapidly changing environment and
balance multiple priorities simultaneously.
- Bending, standing, walking, lifting, sitting, carrying,
repetitive motions typing- filing - writing,
This job description is not all inclusive, additional duties may
At Thermo Fisher Scientific, each one of our 70,000
extraordinary minds has a unique story to tell. Join us and
contribute to our singular mission-enabling our customers to make
the world healthier, cleaner and safer.
Keywords: Thermo Fisher Scientific Inc., Cambridge , Supervisor, QA NTO, Other , Cambridge, Massachusetts
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