Quality Assurance Co-Op - Fall 2022 (176239BR)
Location: Cambridge, MA
Shift: Monday-Friday, Full Time
Co-Op Notes:
- This is a 5-6 month, Full-Time Co-Op opportunity
- Spring Co-Ops will start in January 2022 and end in June 2022; Fall Co-Ops will start in July 2022 and end in December 2022.
- All Co-Op roles are intended to be on-site; this is not a remote position.
- Your school should have a defined co-op program to participate.
- Some relocation assistance may be provided, as needed.
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.
Location/Division Specific Information
Viral Vector Services (VVS), part of Thermo Fisher Scientific, is a dynamic gene therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients. The VVS Global Engineering team is a cross functional engineering group supporting over $150 Million in capital investments across locations in Massachusetts and Florida. Based out of Cambridge, MA, the Global Engineering group works to establish engineering standards/systems for the company and introduce new manufacturing technology in addition to capital project execution.
Description
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.
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/ 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.
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