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Document Control & Compliance Specialist

SinnovaTek

SinnovaTek

Legal
Middlesex, NC, USA
Posted on Oct 17, 2024

Job title

Document Control & Compliance Specialist

Reports to

Manager, Food Safety & Quality Assurance (FSQA)

Job purpose

Position is responsible for the maintenance and management of the Compliance & Quality Assurance programs at Firstwave Innovations. The candidate will manage the development, implementation, and maintenance of food safety and quality programs in compliance with government regulations, the SQF code, Kosher requirements, Organic requirements, and all customer expectations. The position will support the utilization of tools such as auditing, statistical and process evaluation, trend analysis, and coaching to achieve continuous improvement and business objectives. Position requires an individual with a previous history of successfully managing a team in a plant environment.

This position will work closely with various departments to assist in the development of robust quality programs and drive continuous improvement. Help guide the training required for each documentation production group based on key performance indicators, follow-up on corrective & preventive actions, and offer solutions to address any deficiencies.

This candidate should have experience with consumer-packaged goods in an FDA regulated facility. Experience with aseptic and/or hot fill operations is a plus.

Duties and responsibilities

Acts as the back up SQF Practitioner

Achieve, implement, maintain, and hold the SQF Certification Edition 9.0 Modules 2 and 11

Maintains Organic Certification and Kosher certifications for products, services, and customers by working directly with the certification bodies

Participates in all 3rd party scheduled audits, regulatory audits, customer audits and provides all findings evidence to management team and auditor upon completion

Maintains the supporting data for “regulatory evidence” including FDA required to prove they have produced safe and wholesome products.

Assit in developing and maintaining programs and procedures in line with audit & customer-specific goals including SOP’s; SSOPs, Forms, PRPs, Work Instructions, Training Material

Develop and maintain all customer Food Safety Plans in conjunction with the Commercialization team to meet customer expectations and regulatory compliance.

Ensure compliance to GMP, HACCP, food safety, quality SOPs & standards throughout the facility

Stay up to date with regulatory changes based on FDA, Organic, SQF, Supply Chain, USDA food laws.

Audit FSQA activities ensure that all the sampling, testing, and analysis of all in-bound materials, in-process products, and finished goods are in compliance with food laws, food safety programs, and company and customer standards for quality.

Reviews all internal and external audit findings by gathering and compiling detailed reports of findings and implement CAPA for continuous improvement

Implement and maintain all CAPAs, Customer Complaints, Deviations, Internal Audit Findings

Able to assist in the investigation of a product/process failure, determine the root cause and take prompt corrective actions, while minimizing product exposure and production down time quickly and thoroughly.

Helps prevent deviations from filed FDA product filings or product failures by working with FSQA and Production members to drive continuous improvement and long term effectiveness of those decisions

Schedule, maintain, and ensure proper calibration & performance of equipment & procedures

Maintain traceability for holds, work in progress, & palletized finished goods

Maintain records & documentation following internationally recognized guidelines

Support internal audits for food safety, quality, OSHA/safety, SQF & chemical compliance

Flexibility to assist on the floor during production runs and other departmental needs for compliance

Assist in the promotion of a strong & positive food safety culture

Uphold SQF requirements including promotion of a strong & positive food safety culture

Active involvement in implementation, upkeep and continuous improvement of food safety as part of an interdisciplinary team

Stewardship for our B-corp mission to promote worldwide health and wellness by fostering the delivery of high quality, healthy foods through sustainable methods.

Qualifications

· BS Degree in Food Science related field with a minimum of 3 years food safety & quality assurance experience

Experience with food products, fluid products or aseptic processes preferred.

Proven Track Record in Quality Assurance/Sanitation Environment.

Knowledge of Excel, Word, and PowerPoint required.

Some experience with Continuous Improvement Processes is desirable.

Excellent organizational, oral and written communication skills.

Strong team building skills and ability to train others.

Strong information gathering, investigative, and troubleshooting skills.

Ability to work well with others.

A "self-starter" requiring minimal direct supervision but a team player as well.

Experience with Statistical Process Control desired.

3+ years management experience with 3+ direct report team members

BPCS, HACCP & PCQI certified, knowledge of GMP

SQF Practitioner experience preferred.

Understanding of FDA & GFSI food manufacturing standards

Working knowledge of all current OSHA and safety standards

Attention to detail & effective communication

Must work well in teams and demonstrate behavior conducive to promoting strong teamwork

Must possess a positive attitude in a fast-paced & changing production environment

Physical Requirements

Ability to stand and walk for 8-hour shifts

Perform repetitive or continue behavior including lifting 20-30 pounds

Occasionally lift up to 50 pounds at times

Frequent bending, crouching, or twisting

Work in various adverse conditions such as tight or enclosed spaces, heights, and temperature extremes to complete work assignments

Ability to work in fast-paced production environment