Compliance Specialist III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to 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.

DESCRIPTION:

Assists in establishing current quality systems as they pertain to current industry, regulatory and customer requirements for investigational new drugs, biologics and/or medical devices and maintaining operations in a state of control. Also assists the QA Director in maintaining the established systems.

• EstablishesStandard Operating Procedures (SOP),performsroutine maintenance of SOPs, including periodic reviewstoassurealignment of systems with regulatory requirementsand global requirements. Provides training whenrequiredtoassureretention.

• Audits departments for compliance to the quality systems, generating audit reports,identifyingtrends, andestablishingperformance of the quality system

• Provides quality oversight ofvendorqualifications,i.e.questionnaires,quality agreements, vendor auditscheduleetc.

• MaintainsChangeControl,Deviation, Out of Specification, Corrective and Preventative Action, Complaintand investigation report system and follow-up actions.

• Assistsinmaintainingcompliance status of the facilityand audit readiness.

• Implements quality compliance and corrective action training.

• Trains new employeesand junior team memberson TFS procedures and cGMP regulations.

• Works independently on projectsas Quality Assurance Representativewith no supervision.

• Maintains current knowledge of ICH requirements toassurecomplianceofQuality systems.

• Responsible for ensuring that all APQR’s are properly generated, reviewed, andsubmitted.

• Partnerwith site (Logistics and Quality Assurance) and network resources to provide oversight of supplier management and site-specific supplier qualityissues.

• Participate in cross-functional teams on process control, improvement, and optimization projects;participatein other continuous improvement projects to enhance clientsatisfaction.

• Other assignments and tasks as required.

REQUIREMENTS:

• Advanced Degree plus 2 years of experience, or Bachelor's Degree in Chemistry, Biology, or related scientific discipline plus 5 years of experience.

• Excellent project management and problem-solving abilities

• Strong written and verbal communication skills in English

• Ability to work independently and collaborate effectively in a matrix environment

• Proven track record of building relationships with suppliers and interdepartmental groups

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.