Quality Assurance Manager

Company: Vit-Best Nutrition
Location: Tustin
Posted on: January 11, 2020

Job Description:

Position Summary Responsible for managing the Quality Assurance systems through the manufacturing process resulting in quality product per cGMP, company SOPs and applicable regulations. - Responsibilities Responsible for the management of Quality Systems throughout manufacturing, Change Control, and Document Control. Oversee the management of inspection process and monitor Quality Assurance parameters during manufacturing ensuring cGMP, Federal Regulations 21 CFR Part 111, and SOP's are followed. Ensure QA activities are managed, reconciled and closed through the Quality Management System. Oversee the Batch Record Review process to ensure proper reconciliation and documentation meets 21 CFR part 111. Responsible for driving adherence to good documentation practices for record keeping throughout the manufacturing process, including log books, reports, MMR's and Batch Record Reviews. Responsible for the Management of the Change Control Board. Responsible for the Management of the Material Review Board. Assist with Supplier Qualification Management and SCAR's. Responsible for overseeing Environmental Monitoring and Preventative Maintenance records. Review and assist with Root Cause Analysis, Containments, and Corrective/ Preventative action plans with Quality and Operations employees. Responsible for rolling out implementation plans that lead to a reduced frequency of deviations, non-conformances, and re-work in manufacturing. Collaborate with other Managers to update company SOP's and provide training as needed. Assist the Internal & External Audit team in managing the execution of corrective actions and effectiveness monitoring. Drive continuous improvement of quality systems to proactively mitigate current and future risks to support business objectives and financial goals. Serve as liaison for QA improvements with clients as needed. Assist with Sanitation activities to meet regulation requirements. Assist in the company-wide continuous HACCP program. Responsible for supervising, training, and administering performance reviews of QA staff. Serve as the QA signature on formal reviews and approvals. Work closely with the QC and Regulatory Affairs managers to align department objectives. Provide formal reports and business improvement plans to Executive Management. Perform other various tasks as determined necessary by Executive Management. Qualifications & Requirements Must have Quality Assurance management experience in a Dietary Supplement or Food Manufacturing facility for a minimum of 10 years or a combination of formal education and work experience. -Must be able to organize and execute formal continuous improvement plans. Excellent organizational, inter-personal, verbal and business writing skills. Proficient in Microsoft office products; Excel, Word, Outlook, etc. Experience in Network-based system, Quality Management System Bilingual (Spanish) desired. - Education & Experience - Bachelor's degree in Biology, Chemistry, or other related field of study in addition to a minimum of 7 years' experience in Quality Management - or an Associate degree with a minimum of 12 years' experience in a Quality Management role. Knowledge of Food and Drug Administration regulations and guidelines including 21CFR Parts 117 and 111.

Keywords: Vit-Best Nutrition, Tustin , Quality Assurance Manager, Executive , Tustin, California