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Food Regulatory Document Control Specialist

Company: Abstrax Tech, Inc.
Location: Tustin
Posted on: July 28, 2022

Job Description:


The Document Control Specialist will play a critical role in collecting and maintaining the quality and regulatory documentation required to support Abstrax operations and products from concept to commercialization. This is a non-supervisory role that requires strong collaboration with multiple departments. Candidates with food and beverage experience are preferred as we manufacture consumable products.


Duties may include, but are not limited to:
* Maintain a safe work environment.
* Demonstrate Good Manufacturing Practices (GMP) and provide support for internal audits and customer visits.
* Strictly follow all SOPs and Procedures.
* Help the department to maintain a document management system compliant with ISO and GFSI.
* Responsible for creation, review, approval, routing, training, storage and archiving of new and revised controlled documents.
* Maintain records/logs/matrix (e.g., Training Docs/Matrix, SOPs, WIs, Calibration Matrix, NCRs, CARs) to comply with business and regulatory requirements.
* Review records for accuracy and completion.
* Assist in approval of new raw materials and suppliers.
* Accurately maintain raw material and finished product information databases.
* Contribute to identification of alternate supply lines.
* Maintain the Approved Supplier List including tracking vendor performance.
* Utilize information databases to generate finished product documentation and store in highly organized, easily accessible, central location.
* Provide appropriate responses to Customer Questionnaires.
* Manage Case system to support Customer Service, Sales, R&D, QA, QC and Regulatory departments with appropriate raw material and/or finished product documentation.
* Identify emerging regulatory and quality related topics of customer interest to VP of Regulatory and Quality.
* Complete non-routine jobs as assigned by VP of Regulatory & Quality or other management.
* Work cooperatively with co-workers.
* Maintain regular and punctual attendance at work.
* Performs other duties as assigned.

* Extreme attention to detail.
* Excellent oral, written and presentation communication skills.
* Proficiency using Microsoft Office Programs and information databases.
* Ability to define problems, collect data, establish facts, and draw valid conclusions.
* Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
* Ability to read, analyze and interpret common scientific and technical journals.
* Industry specific knowledge of ingredients, ingredient functionality and product formulas.
* Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
* Ability to effectively plan, organize and prioritize work.
* Ability to work with minimal supervision.
* Ability to work in a fast-paced environment, and manage multiple, changing priorities simultaneously.
* Excellent cross-departmental collaborative skills.
* Ability to sit for long periods of time.
* Visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading.
* Can tolerate frequent exposure to fumes or airborne particles.
* Can tolerate a moderate noise level as found in an office environment.
* Available on call as required to support plant operations.
* Can accommodate occasional travel between facilities (as added).
* Self-directed with the ability to work independently.
* *For consideration for this role, applicants must complete the requested Indeed skills assessments.*

* High school diploma or GED equivalent.
* Bachelor's degree in chemistry, biology, or related field of science preferred.
* 1-2 years of related experience and/or training; or equivalent combination of education and experience

* US work authorization (Required)
* Successfully complete a background check

Job Type: Full-time

Pay: $21.00 per hour

* 401(k)
* Dental insurance
* Health insurance
* Life insurance
* Paid time off
* Vision insurance
* 8 hour shift
* Monday to Friday

Keywords: Abstrax Tech, Inc., Tustin , Food Regulatory Document Control Specialist, Other , Tustin, California

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