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.     Establishes   Standard Operating Procedures (SOP) ,   p erforms   routine maintenance of SOPs, including periodic reviews   to   assure   alignment of systems with regulatory requirements   and global requirements . Provides training when   required   to   assure   retention.   Audits departments for compliance to the quality systems, generating audit reports,   identifying   trends, and   establish ing   performance of the quality system    Provides quality oversight of   vendor   qualifications ,   i.e.   questionnaires ,   quality agreements, vendor audit   schedule   etc.    Maintains   C hange   C ontrol ,   D eviation, Out of Specification, Corrective and Preventative Action, Complaint   and investigation report system and follow-up actions.   Assists   in   maintaining   compliance status of the facility   and audit readiness.    Implements quality compliance and corrective action training .   Trains new employees   and junior team members   on TFS procedures and cGMP regulations .   Works independently on projects   as Quality Assurance Representative   with no supervision.   Maintains current knowledge of ICH requirements to   assure   compliance   of   Quality systems.    Responsible for ensuring that all APQR’s are properly generated, reviewed, and   submitted .   Partner   with site (Logistics and Quality Assurance) and network resources to provide oversight of supplier management and site-specific supplier quality   issues.   Participate in cross-functional teams on process control, improvement, and optimization projects;   participate   in other continuous improvement projects to enhance client   satisfaction. Other assignments and tasks as required.

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