SUMMARY: Assists the Quality Control Manager with the planning, scheduling, and supervising of the QA Department and directing QA employees to perform the duties associated with QA activities and document control.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE:

Bachelor’s degree in scientific discipline as chemistry, chemical engineering, biology, microbiology, food science, etc. from a four-year college or university; and 3-4 years supervisory experience in a quality control role within food, nutraceutical, or pharmaceutical industry. Master’s degree in scientific discipline as chemistry, chemical engineering, biology, microbiology, food science, etc. and 2 years supervisory experience in a quality control role within food, nutraceutical or pharmaceutical industry or equivalent combination of education and experience. Should have experience working on the floor of a manufacturing facility.

LANGUAGE SKILLS:

Ability to read and interpret documents such as safety rules and procedures. Ability to write routine reports and correspondence. Ability to speak effectively before groups of employees in the Quality Control Department.

MATHEMATICAL SKILLS:

Must be proficient in algebra and acquainted with statistics. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

COMPUTER SKILLS:

To perform this job successfully, an individual should have knowledge of Database software; Manufacturing software; Spreadsheet software and Word and Excel Processing software. Knowledge of Oracle is a plus.

Includes the following, but other duties may be assigned as the company’s needs dictate.

• Carries supervisory responsibilities in accordance with the company policies and applicable laws.
• Ensure regulatory compliance through implementation and maintenance of cGMP and QMS system.
• Leads site investigations of OOSs, NCMRs, Deviations, Customer Complaints, CAPAs and regulatory bodies findings.
• Presides over MRB, Food Safety and Product Complaint discussions designed for solving production, quality and complaints problems.
• Maintains QA/QC documents, files, protocols, reports and policies in “audit ready” level.
• Maintain Change control and follow Good Documentation Practice principles.
• Organize and maintain Supplier Qualification program.
• Responsible for monthly audits of manufacturing, warehouse, QCs departments for compliance with GMP, GDP, NSF and FDA regulations.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and good documentation practice for all manufacturing processes, quality inspections, sanitation and testing activities.
• Maintain QC and production equipment Calibration records.
• Monitor the QMS implemented programs GMPs, Good Hygiene Practices, HACCP, Allergen Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc., and ensure compliance by all employees and other personnel in the manufacturing facility.
• Assist with QMS annual system review and performance including the review and updates of HACCPs, Food Safety and Sanitation plans.
• Assist in preparation and participate in the FDA, NSF, Kosher, Halal, CCOF, Texas DSHS and other parties’ inspections and audits.
• Back up for QC management on Release/Reject decision making for raw materials, intermediates and finished products.
• Assist in organizing and maintenance of Company’s Training program.
• Assists with other work programs, projects, activities related to Product Quality and Safety.
• Review quality documents like Batch Records, Product Specifications, COAs.
• Supervise, trains, motivates QA personnel.
• Share knowledge, skills and information with production departments and team members.
• Other tasks and functions as assigned by the QC/QA manager.