Thermo Fisher Scientific Intern - Quality Assurance in Greenville, South Carolina
Quality Assurance Specialist Intern will assist in establishing quality systems as they pertain to current industry, regulatory and customer requirements. The intern will also assist the QA Supervisor in maintaining the established systems.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Assists in review of batch records and corresponding documentation prior to product disposition
Distributes and tracks controlled copies of batch operating procedures (BOP) for manufacturing campaigns
Assists and manage in establishing Standard Operating Procedures (SOP)
Issues, tracks and controls laboratory log sheets for all scientific personnel.
Assists in routine maintenance of SOPs, including periodic reviews
Reviews shipping documents prior to all shipments of product
Maintains up-to-date raw material specifications and issues controlled copies to purchasing and Quality Control.
Issues deviation report numbers, out of specification (OOS) numbers, Corrective Action Report (CAR) numbers and change control.
Assists in preparation for customer visits prior to audits and collecting documents during audits for review by the auditor or investigator.
Reviews QC analytical results to assure that material meets specifications and releases/rejects as dictated by findings.
Updates control document books as new issuances/up-dates are issued.
Maintains training records and training record program, updating as necessary, for all personnel.
Assigns SOP, Batch Record, validation, protocol, cleaning, investigation and change control numbers. Ensures documents are received and filed in a timely manner.
Performs raw material review and disposition, in addition to maintaining computer system.
Maintains raw material vendor relationships, i.e. creating specs and obtaining of C of A.
Maintains change control and investigation report system and follow-up actions.
Reviews and releases final products
Assists in maintaining compliance status of the facility
Effectively communicates with management.
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.