Job Description

Job Title: QA Operations Specialist I - Nights
Requisition ID: 145203BR

When youre part of the team at Thermo Fisher Scientific, youll 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 youll be supported in achieving your career goals.

Location/Division Specific Information

This position will site at the 250 Binney Street, Cambridge, MA site of Viral Vector Services (VVS) and report into the QA Operations Supervisor.

Hours: Rotating 2/2/3 Night Shift 7:00PM-7:00AM

How will you make an impact?

The Quality Assurance Specialist will be the primary point of contact for the customer on all matters related Quality Assurance Operations. 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 Brammer Bio directives and procedures, customer requirements, and regulatory 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. Additional responsibilities may include support in personnel interviewing/training, compliance with policies & inspections. Provides feedback for personnel development.

* 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.
* Proficiency in project management, processes, improvement and ability to address through risk assessment.
* Provides feedback for personnel development.

Knowledge, Skill, and Requirements:

* Bachelors Degree in Sciences or 1-2 years Quality related experience preferred
* 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.
* Proficient at public speaking, teaching, facilitating to peers, senior associates, and area management within their operational group.

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

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.

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.