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Food Regulatory Document Control Specialist

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

Job Description:

POSITION SUMMARY 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. ESSENTIAL FUNCTIONS 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. ADDITIONAL QUALIFICATIONS 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. EDUCATIONAL REQUIREMENTS 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 ADDITIONAL REQUIREMENTS US work authorization (Required) Successfully complete a background checkJob Type: Full-timePay: $21.00 per hourBenefits: 401(k) Dental insurance Health insurance Life insurance Paid time off Vision insuranceSchedule: 8 hour shift Monday to Friday

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

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