Quality Assurance Co-Op
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. You’ll have the opportunity to grow and learn in a culture that empowers your development. We have built an inclusive, global environment that values the power of diverse talent, backgrounds, and experiences to drive speed, efficiency, innovation, and growth.
How will you make an impact?
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.
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/ studying a degree in Sciences
- 2-5 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.
- Ability to function in a rapidly changing environment & handle multiple priorities
- A flexible work schedule is required
- Ability to lift up to 25 lbs
Equal Employment Opportunity & Accessibility
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.
Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
Thermo Fisher does not offer employment in this position to holders of F-1, J-1, H-1, OPT, and CPT Visas for the purpose of obtaining practical experience.