Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
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.
Assistsinestablishingcurrentquality systems as they pertain to current industry, regulatory and customer requirementsfor investigational new drugs, biologics and/or medical devicesandmaintainingoperations in a state of control.Alsoassiststhe QA Director inmaintainingthe 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
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 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, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team 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, Patheon and PPD.
For more information, please visit www.thermofisher.com.
