Quality Assurance co-op
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals. Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.
How will you make an impact?
Onsite Co-op in Cambridge MA - January to June 2023
This position requires a highly motivated, tenacious, self-starter who can assimilate new information quickly and enjoys working closely with others within a fast-paced project execution environment. The individual will perform activities in support of dispositioning product and/or raw materials while ensuring compliance with Thermo Fisher standards.
Essential Responsibilities:
Responsible for contributing to key functional, tactical, and operational aspects of VVS operations at the Cambridge site. This includes approval & oversight of MFG and QC activities associated with CAPA, deviations, and other documentation related to MFG and QA operations.
- Batch Record/Logbook review
- Document/Label Issuance and archival
- Quality support for Critical MFG Operations on the floor
- Initiation and approval of deviations through Trackwise
- Process improvement initiatives
- Perform Acceptable Quality Limit (AQL) of Fill Finish vials
- EM Data review for Room release
- Support third party audits, external customers, and Agency inspections as needed and support internal activities concerning any identified nonconformities
- Responsible for evaluating impact, ensuring adherence to compliance standards, including technical ability to evaluate & approve these quality system elements, as delegated by management.
- Provides feedback for personnel development.
Knowledge, Skill, and Requirements:
- Enrolled in a Undergraduate program studying a degree in Sciences
- 2-3 years’ of completed university coursework
- Knowledge of biologic manufacturing, vector manufacturing, fill finish, or label and pack processes
- Strong interpersonal and communications skills; written and oral.
- Ability to perform as an individual and part of a team, self-motivated
- Solid understanding of US, EU and ROW cGMP guidelines and requirements preferred.
- Ability to recognize, understand and respond to situations requiring further evaluation and report these events (process, safety, personnel, etc..) to senior specialists or area management.
- Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment
- Ability to understand operational documents for GMP compliance, accuracy and completeness. Ability to work by influencing a matrix management system and to gain the cooperation of others.
- Strong client-facing interpersonal skills coupled with a concern for impact.
- Strong time management and organizational skills.
- Pragmatic, proactive yet flexible approach in the working environment.
- Excellent written and oral communication skills both internal and external.
- Able to manage multiple priorities and demonstrate self-control
- Ability to resolve conflict within project teams
- Detail Oriented Self-Starter
- Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
Physical Demands:
- Ability to function in a rapidly changing environment & handle multiple priorities
- A flexible work schedule is required
- Ability to lift up to 25 lbs
Applicants must have unrestricted US work authorization. Forms of CPT and OPT are forms of restricted work authorization.
At Thermo Fisher Scientific, each one of our 100,000 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.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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 www.thermofisher.com.