Work Schedule
Other
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Warehouse
Job Description
Job Description
Position Summary:
Join Thermo Fisher Scientific Inc. as a Lead QA Technician. Support quality systems, regulations, and the Quality Manager.
Key Responsibilities:
* Manage SOPs, including Document Control as Coordinator on eDMS.
* Review and approve Trackwise QRs including CAPAs, deviations and complaints
* Draft & approve operational documentation.
* Perform quality reviews of change controls and status control of products/materials.
* Manage items and content on SFLMS and conduct supplier assessments.
* Ensure compliance with our QMS and applicable regulations/standards.
* Assure adherence to EU GMP and IGJ regulations to maintain site licenses.
* Perform duties as an approved Archivist, verifying quality tasks.
* Support client audits and internal audit programs as needed.
* Provide training and proficiency assessments.
* Check operational documentation for ALCOA+ and Good Documentation Practices.
* Perform QA related tasks assigned by the site Head of Quality.
* Support QC incoming inspection and disposition activities.
* Perform Quality Control related tasks as required.
* Travel as the need arises and perform off-site work when vital.
Minimum Requirements/Qualifications:
* Degree or equivalent experience in relevant subjects or at least 1 year of GMP experience.
* High degree of accuracy and attention to detail.
* Ability to interpret general procedures and regulations.
* Strong problem-solving skills and the ability to present information effectively.
* Proficient in MS Office and capable of mastering clinical trial database systems.
* Excellent verbal and written communication skills.
* Proven teamwork skills and the ability to operate under pressure.
* Employment is subject to a 10-year history screening for criminal records, qualifications, previous employment, and credit history.
* Proficient in English.
Although not required, the following would be preferable:
* Live no more than 30 minutes driving time from the facility.
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