QA Specialist
Description:
Job Description
JobsRUs.com is seeking to hire a QA Specialist for our client in South Haven!
Benefits Available!
Weekly Pay!
$35-$40/Hour
Shift: 40 hours per week 7-4 or 7:30-4:30 M-F onsite but flexible around start time
Job Description
The Quality Specialist audits all aspects of Site operation, facilities, processes, products and documents for compliance
to GMP, SOP and Site requirements, documents the results, resolves any nonconformance and coordinates necessary
corrective actions. Coordinates validation of all aspects of Site operation, facilities and processes for compliance to
GMP, SOP, and Site requirements Prepares responses and Certificates of Analysis for customers. Makes disposition of
finished product by performing the following duties:
. Review and approve final product analytical data, review batch product deviations, assessing quality impact and
propose corrective/preventative actions, generate product Certificate of Analysis and perform product release.
. Management of Change - review and approve revisions to master batch production records, analytical test
methods, cleaning procedures, SOPs, Forms, Master Plans and Equipment Modifications.
. Review and approve Out of Specification laboratory investigations, Deviation Reports, ICARs.
. Review and approve validation (prospective, retrospective and concurrent) of equipment, facilities, processes
and methods.
. Annual Product Quality Reviews - perform and document Quality portion of the review; propose
corrective/preventative actions based on the review to improve product/process control and quality
compliance.
. Host Customer Audits as required.
. Conduct periodic internal audits of the facility, document the results, and coordinate the corrective actions.
. Participate in FDA Audit as required.
Required Skills, Experience and Education
. 4-year BS/BA degree required
. cGMP experience is a plus but not required
. Good communication skills and ability to communicate decisions to cross function teams is a must
#ZR
Full-time