Thermo Fisher Scientific is currently seeking a QA Compliance Lead for an exciting opportunity to join our team in Greenville, SC.
The QA Compliance Lead Assists in establishing quality systems as they pertain to current industry, regulatory and customer requirements. Also assists the Quality Supervisor(s), Quality Manager(s) and Site Quality Head in maintaining the established systems. Provides quality assurance project support for cGMP operations.
Responsible for technical writing and/or front end review for SOP and on the job training materials.
Provide support and delivery of training to site personnel on compliance related matters as well as focused areas of concern (i.e Root cause analysis, investigation techniques, corporate and site initiatives)
Assist in driving improvements and reporting of key quality indicators and tracking metrics.
Assist in providing the internal closure of quality documents (such as Change Control, Deviation, CAPA, and OOS) within the 30 day window as specified in the applicable SOPs. If the document cannot be closed, the QA Compliance Lead will coordinate the written assessment memo as directed in the applicable SOPs.
Provide support for Client and Internal Audit programs as well as conducting Disposition of final products
Assists in routine maintenance of SOPs, including periodic reviews • Assigns controlled GMP numbers such as, but not limited to, deviation report, change control, OOS, and PQI
Maintains raw material vendor relationships, i.e. creating raw material specifications
Assists in maintaining Change Controls, CAPA, and Deviation Report system and follow-up actions.
Reviews Deviation Reports, Change Controls, OOS, PQI etc. The function will provide technical assistance where warranted to improve the quality of the reports.
Assists in preparation for customer visits prior to audits and collecting documents during audits for review by the auditor or investigator
This role will also assist with Document Control functions as related to these quality documents as required, including but not limited to filing and scanning for document retention activities
BS degree in Chemistry, Biology or related scientific discipline preferred
Associate's Degree (AA/AS) with two- four years’ relevant experience – will be considered Experience
3+ years in a regulatory environment – required
Previous Pharmaceutical or cGMP experience - preferred
Knowledge of Database/spreadsheet software; presentation software and Word Processing software.
Able to obtain DEA registration.
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 70,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.
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.