QA Specialist at Eagle Labs Inc – Oldsmar, Florida

GENERAL PURPOSE

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.

POSITION 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

MINIMUM QUALIFICATIONS

Education

• High School Diploma or equivalent

Experience

• 2 years cGMP experience in a regulated industry

• 2 years providing quality assurance support to cGMP pharmaceutical or nutraceutical production (other regulated industry

Knowledge, Skills, and Abilities

• 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

Certification or License

• None