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Compliance Lead

Company: Thermo Fisher Scientific
Location: Greenville
Posted on: February 13, 2019

Job Description:

Job Title: Compliance Lead
Requisition ID: 86603BRWhen you---re part of the team at Thermo Fisher Scientific, you---ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you---ll be supported in achieving your career goals.Location/Division Specific Information
Greenville, SCHow will you make an impact?
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.What will you do?
--- 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 activitiesHow will you get here?
Education
--- 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.At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission---enabling our customers to make the world healthier, cleaner and safer. Apply today! http://jobs.thermofisher.com 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.

Keywords: Thermo Fisher Scientific, Greenville , Compliance Lead, Other , Greenville, South Carolina

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