Quality Specialist Location:Conway, AR
100,000 - 200,000
Job Description:
Job description
OVERSIGHT
Implementation, execution and maintenance of internal auditing program
Develop, author and maintain protocols for qualification, validation, recertification and preventative maintenance of primary/ secondary process equipment, utilities and processes.
General oversight of CAPA program, documentation and CAPA implementation
Review and approval of annual product review.
Review and approval of environmental trending data.
General oversight of batch record generation, revision, issuance and review
RESPONSIBILITIES
compliance to cGMP regulations applicable to 503(b) Outsourcing Facilities requirements
Compliance to SOP and quality systems
Author, revise and train on SOP protocols and reports
Participate and contribute to the controlled document, change control, deviation, complaints and investigation quality systems
Ensure processes and products are appropriately validated
Monitor that equipment PM and calibrations are completed within required time frames
Support the company functions involved in cGMP activities to build a culture based on problem solving