Quality Specialist III, Lot Disposition

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 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*

This position will report to the Manager, Lot Disposition, Viral Vector Services division of Thermo Fisher Scientific. It will sit in our Cambridge, MA office.
* Shift*
Mon-Fri 8am - 5pm

* How will you make an impact?*

The Quality Assurance Lot disposition professional will be the primary point of contact for the customer on all matters related to Quality Assurance Lot Disposition. 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 while ensuring compliance with Thermo Fisher directives and procedures, customer requirements, and regulatory standards.

* Position Description/Summary:*

The QA Lot Disposition professional is responsible for oversight of lot disposition at the Cambridge facility.
This individual will work closely with the Quality Operations team to ensure timely and compliant release of batches. The incumbent must be a strategic thinker, excellent communicator, collaborative and possess the ability to make sound, time-sensitive decisions in support of the operations.

* Essential Responsibilities:*
* Provide quality expertise and oversight of the batch disposition process.
* Responsible for compilation and review of batch release documentation packages.
* Works collaboratively with manufacturing and cross-functional stakeholders to ensure deliverables are met to support disposition.
* Represent the organization and act as SME during external (client and regulatory) inspections as needed
* Responsible for complaint investigation and resolution.

Knowledge, Skill, and Requirements:

* Knowledge of FDA/EMA regulatory requirements applicable to biologics or pharmaceuticals.
* Experience with Quality oversight of batch disposition.
* Excellent organizational skills and analytical and problem-solving abilities, strong verbal and writing skills and good interpersonal and leadership skills.
* Possesses exceptional time management and multi-tasking abilities to meet commitments and deadlines.
* Bachelor's Degree or equivalent experience.
* At least 5 years of work experience in biotech/biopharma.
* 1+ Years prior management experience preferred.
* At least 5 years of direct GMP experience.
* Experience interacting with external auditors as an SME.
At Thermo Fisher Scientific, each one of our 70,000 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.

Keywords: Thermo Fisher Scientific, Cambridge , Quality Specialist III, Lot Disposition, Other , Cambridge, Massachusetts