Quality Document Control Specialist

OBJECTIVE: Perform hands on tasks and working knowledge of processes, policies, and procedures

associated with quality, food safety and material integrity, assist in management of customer external databases.

ESSENTIAL REQUIREMENTS:

· Working knowledge as a Document Control Specialist of the following:

§ Quality Manual

§ Quality Policy

§ Quality Management System (QMS)

§ SQF –Food Safety & Food Quality

§ Document Control Procedure

§ Calibration Procedure – validate accuracy and appropriate placement of calibration stickers

§ Control of Records Procedure – maintain all traceablility and testing records

§ Corrective and Preventative Action Procedure

§ Control of Nonconforming Product Procedure

§ Allergen Controls including awareness, labeling, and clean up protocol involved in knowing what allergen(s) need to be tested.

§ Regulatory requirements/compliance concerning OU, SQF, GMP’s, OSHA, HACCP and USDA

§ Understanding of the 21 CFR Part B cGMPs for Dietary Supplements (21 CFR Part 111)- Be able to be trained on the regulations of Dietary Supplements and perform the job duties to maintain the requirements.

§ Understand the process for pulling and sending of all dietary supplement ingredients for identity testing.

§ Understand how to perform various checks required for dietary supplement packaging materials and record findings for each lot number evaluated.

§ Understand how to perform the required checks necessary on the packaging of dietary supplements and ensure that the proper documentation is obtained for each production run.

· Communicate with raw product suppliers to verify compliance with applicable specifications and maintain

appropriate records concerning verification

· Maintain current database of food ingredients for specification, Letters of Guarantee, SDS, Kosher, Quality programs, or audit compliance certificates for all of our ingredient suppliers.

· Head up the HACCP Team to ensure new products are properly reviewed and documented in the plan along with ensuring a yearly review is performed of all the HACCP plans to verify compliance.

· Understand all the SQF requirements for Modules 2 and 11 along with the Food Qualtiy modules.

· Maintain the Quality Hold Log to ensure everything is documented and non-conforming product is tagged and isolated properly along with ensuring final dispositions are performed and documented.

· Ability to create and update QMS documents and overall maintain the QMS system.

· Maintain records for all the primary packaging components to ensure FDA compliance.

· Head up the Glass & Hard Plastic audits to ensure they are done in a timely manner at the prescribed internvals.

· Provide both orientation and refresher training on regulatory and third party audit training and maintain and records.

· Maintain and keep records of quality Corrective Actions issued and ensure they are resolved in a timely manner.

· Inspect and sign off on all generated TVS labels for products and maintain signed label documents as records.

· Review all Quality paperwork by signing and dating to ensure all products run meet specifications.

· Maintain and update the Quality KPIs on a monthly basis.

· Provide monthly updates to Management key for third party certification criteria and Quality measurements.

· Communicating directly with suppliers and customers, creating COAs, writing batch records, become the primary contact for third party testing.

· Coordinate scheduled calibrations of equipment (scales, metal detectors) throughout the plant to ensure compliance for SQF.

· Coordinate and schedule Internal Audits required to verify SQF compliance for the various modules.

· Assist with facility internal audit program

· Understand how to perform allergen testing, interpret and communicate results

· Understand how to perform ATP testing of equipment, interpret and communicate results

· Communicate, coordinate, and ship product and environmental samples to external labs

· Ability to perform a successful mock recall within four hours of recall initiation

· Understand how to perform final product testing and inspection concerning moisture, and bulk density analysis; in some cases, depending on customer requirments, baking and product performance testing and verifications

· Perform receipt inspection on incoming products when required.

· Understand how to perform environmental microbial sampling and maintain associated documentation and samples post clean up and for packaging line areas

· Understand how to perform air plate testing for the various filling and blending rooms.

· Understand how to test the compressed air sites identified at TVS and send off for 3rd party micro testing.

· Gather and compare all incoming COAs for ingredients to ensure specifications on COAs are being met and maintain these as official records.

· Understand how to gather, store, and maintain product samples for sending off for a 3rd party lab testing and for TVS retains.

· Effectively communicate on multiple levels, using verbal, written, and computer skills

· Possess visual acuity to assess quality standards and material integrity; clarify and provide guidance to personnel as needed

· Ability to work independently

· Assist in any of the quality functions as needed.

QUALIFICATIONS:

· Minimum High School Diploma/GED from an accredited school recognized by North Carolina and a minimum of 1 year experience in quality, inspections, or manufacturing operations or

· Degree or certification in closely related field of study and a minimum of 24 months experience in quality, inspections, or manufacturing operations

· Must have good computer skills in programs such as Excel and Word.

· Ideally knowledgable in the SQF program with an understanding of it’s requirements in the food manufacturing and packaging industry.

· Ability to stand for an entire shift, lift, twist, bend, stoop, push, and carry up to 15 pounds.

· Ability to perform functions that require manual dexterity, ability to read, write, and possess basic math skills, including basic statistics, comprehension of weights and weight calculations, percentages, number sequences, and distinguish between colors

· Some tasks may require the ability to lift and carry 60 pounds and work at heights above ground level