QA Documentation Specialist

Title:  QA Documentation Specialist
Location:  Monroe, NJ
Schedule:  M-F Full Time
Type:  Direct Hire

Responsibilities:
The QA Documentation Specialist I plays a critical role in ensuring quality compliance by overseeing various types of documents related to production and operational processes. This role involves reviewing changes to key documents like master production records, SOPs (Standard Operating Procedures), analytical methods, and specifications to ensure that they align with quality standards and regulatory requirements. 

• In liaison with leadership, manages the quality and safety documentation programs, ensuring compliance with all relative government and 3rd party certifications (SQF, OSHA, FSMA, FDA, FSVP, APHIS USDA, etc.).
• Responsible for document change control, obtaining additional clarification/information as necessary, and ensuring that all relevant supporting documentation for a given document change is included.
• Communicates and coordinates with representatives of Manufacturing, Distribution, Sanitation, Packaging, Regulatory, EH&S, Engineering, and other site personnel to obtain necessary background information and technical data to ensure timely review and completion of documents relevant to industry changes.
• Ensures our CAPA and correction program meets OSHA, FSMA, and SQF requirements.
• Conduct safety and food safety documentation audits routinely on the operation floor to ensure programs match our internal programs. 
• Works with quality management on the self-inspections and internal audit program. Followings up on corrective action efficacy.
• Pre-approves and routes SOP’s and WI reviews for required signature approval in the electronic Document Management System (DMS).
• Assures all controlled documents are current and audit-ready.
• Verifies safety and food safety monitoring records for accuracy and follows up with process owners on nonconformances.
• Works closely with Quality and Safety leadership on facilitating training (hourly, new hire, temp to perm, temporary, and quarterly refreshing training required to sustain compliance with OSHA, FSMA, and SQF requirements.
• Develop new or revised training programs relative to our operations via ALCHEMY to administer to all required personnel.
• Tracking personnel training status prior to hire or as scheduled.
• Other responsibilities as assigned by management. 

Requirements:

• Must have understanding of SQF, SOPS, FDA. 
• Previous audit experience
• Bilingual preferred. 
• SQF Practitioner, HACCP certified, FSMA-PCQI certified.
• Working knowledge of FDA and State laws related to Food or Pet food products storage, handling, and distribution.
• Has experience in internal audits.
• Experience in the process of change control.
• Ability to balance multiple priorities simultaneously and manage time appropriately.
• Accurate recordkeeping & reporting skills.
• Proficient in Microsoft Office Suite (Word, PowerPoint, Excel, Outlook).

Ref: #558-Scientific