QA Operations Lead

Company: Thermo Fisher Scientific
Location: Cambridge
Posted on: November 19, 2021

Job Description:

When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale. Join 90,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

* How will you make an impact?*
QA Operations Lot Disposition provides Quality Assurance support real-time for all areas within Thermo Fisher Scientific Lexington facility that are directly or indirectly involved in the execution of Good manufacturing Practices (GMP)-related activities for both clinical and commercial products. This individual will interface closely with other cross-functional groups such as Operations, Facilities, Engineering, QC and Quality. The role will perform lot record disposition preparation for management and work with others to provide the necessary documentation to support lot disposition activity. The individual will perform activities in support of dispositioning product while ensuring compliance with Thermo Fisher Scientific directives and procedures, customer requirements, and regulatory standards.
* What will you do?*
* Coordinate closure of GMP documents to support batch record closure and lot disposition of both bulk drug substance and drug product.
* Interact with manufacturing operators at all levels on the floor during production and off the floor in batch record reviews
* Respond to QA Hotline calls
* Approval of Out of Service and Quality Hold tag outs
* Participate in functional area reviews and ensure departments focus on continuous improvement
* Provide GMP guidance to Manufacturing, QC, Engineering, MSAT and Facilities
* Document all items within shift notes, provide follow-up for other shifts as needed
* Stand in for Supervisor or Manager in meetings requiring QA input
* Make Quality decisions and provide information to defend those decisions
* Demonstrated leadership within the QA Operations team
* Be a source of knowledge for the team
* Assess QA procedures/practices for improvement to ensure compliance
* Perform batch record review and prepare documentation for lot disposition by management
* Perform issuing and tracking of GMP documents and metrics, as applicable
* Work effectively with people, including good investigation, problem solving and organization skills
* How will you get here?*
* Minimum required education: BS/MS in Biology or related science discipline and 6+ years of experience in a cGMP manufacturing or QA Operations environment, with strong knowledge of GMP operations and regulations.
* Proficient in cGMPs applicability and decision making
* Experienced in batch record review and manufacturing operations
* Experienced in quality record completion and content
* Experience in setting up GMP operations and systems in a new facility and experience in cell or gene therapy preferred.
* Familiarity with SAP, TrackWise, Document Management System (DMS), and Laboratory Information Management Systems (LIMS) preferred
* Demonstrated ability in decision making and providing direction to operators on next steps
At Thermo Fisher Scientific, each one of our 80,000 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.

* Apply today! *[http://jobs.thermofisher.com](http://jobs.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.

* Accessibility/Disability Access*
Job Seekers with a Disability: 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 are a job seeker with a disability, or assisting a person with a disability, and 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.
* This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Keywords: Thermo Fisher Scientific, Cambridge , QA Operations Lead, Other , Cambridge, Massachusetts