QA Specialist

Eagle Labs Inc•Oldsmar, FL

13h

About The Position

The Document Controls Specialist will be responsible for overseeing the administration and control of cGMP documents to ensure their accuracy, quality and integrity. Responsibilities include adhering to record retention policies, safeguarding information and retrieving data more effectively and efficiently.

Requirements

High School Diploma or equivalent
2 years cGMP experience in a regulated industry
2 years providing quality assurance support to cGMP pharmaceutical or nutraceutical production (other regulated industry
Strong organizational skills, excellent communication skills, and good attention to detail
Basic understanding of CFR Part 111, and CFR Part 211 and GMP
Must be able to read and understand English job instructions and safety requirements
Ability to use word processing, excel, SAP systems

Responsibilities

Manage and maintain document control systems and databases
Ensure all documents are properly stored and easily accessible
Coordinate with various departments to ensure document accuracy and completeness
Monitoring of SOPs revision stratus
Review and update documents for accuracy and completeness
Maintain records of document requests and retrievals
Assist with SIR documentation of non-conformances associated with deviations, CAPAs, investigations, customer complaints
Ensure proper documentation retrieval for customer requests, certifications, regulatory etc.
Maintain consistent and documented compliance will all relevant Good Manufacturing Practice (GMP), Data Integrity (DI), quality and best practice requirements
Other job duties as require