ESSENTIAL DUTIES AND RESPONSIBILITIES RELATED TO DOCUMENT CONTROL

The Document Control / Regulatory Affairs Specialist is responsible for:

Operating and maintaining manual and electronic Document Control Systems to meet divisional and individual plant requirements. Maintaining a central repository for all QA controlled documentation Maintaining corporate document flow across the facilities Reviewing, controlling, Maintaining and storing Quality System documentation and records Maintaining documents received from customers. Oversee all filing areas and document retention.

ESSENTIAL DUTIES AND RESPONSIBILITIES RELATED TO REGULATORY AFFAIRS

Operating in accordance and compliance with regulatory affairs to be able to disburse Questionnaires to key individuals on all facilities Requesting verification to Corporate Tactical RFI team Storing RFI Responses and related documents in electronic site Storing electronically certificates and audit reports from all plants

Document Control / Regulatory Affairs Specialist must possess a comprehensive knowledge of:

Quality Business Systems

GFSI/Food Safety programs such as BRC, SQF and YUM!

The industry’s cGMP standard 21 CFR Part 110,

Electronic Records 21 CFR Part 11 & 21 CFR Part 174, 21 CFR Part 175, 21 CFR Part 174.

Green Certifications: FSC, SFI and PEFC

The position requires a thorough working knowledge of Office and computer software such as Adobe Professional.

Reports to Quality Director.

Document Control System — Owner Control Document Issuance — Owner Customer Quality Questionnaires/RFI’s (Inquiries distribution/follow up on responses back to customer) — Owner Audit Certificates and Reports — Owner Change Control Records — Owner Mock Recall — Owner Internal Audits — Team member GFSI Implementation — Team member