Share Email Opening Title Director of Quality Assurance & Regulatory Affairs  About the Organization Welcome to Blue Marble - your home, our home! We are a family business with core values of work hard, play hard. We are proud to offer Ultra-Premium Co-Packing, Private Label, and Canning Services. Come join our team!   Full-Time/Part-Time Full-Time   Exempt/Non-Exempt Exempt   Number of Openings 1   Description Blue Marble Productions, Inc. is a world-class developer, processor, and co-packer of branded and private label alcohol and non-alcohol-based products for the beverage industry. The Director of Quality Assurance & Regulatory Affairs (DoQ) is responsible for establishing and maintaining a quality management system to ensure our facilities, equipment, associate's, methods, processes, and procedures conform to the standards and regulatory requirements for overall product quality, safety and reliability. The DoQ will define, develop, and promote the culture of a quality driven mindset across the organization. Responsibilities: Responsible for the development, implementation, and strict adherence to a quality program. Develops and/or reviews standards, policies, and procedures for all functions and departments involved with or related to the production of all products. Responsible for products being in compliance with all regulatory and company standards. Develops/maintains the Quality Management System (QMS), including creating/updating of SOPs, training, implementation, and monitoring effectiveness and compliance across the organization with all local, state, and federal regulatory requirements. Reviews and resolves quality control problems/concerns with quality team and cross-functional leaders including vendors, customers, quality control personnel, and any personnel related to production. Inspects completed quality control checklists, forms, and other documents; randomly inspects and verifies quality control checks for conformance to prescribed standards. Schedules and performs internal quality audits and reports findings to senior management; develops corrective action plans and ensures timely resolution of findings. Leads all external audits from any 3rd party notified bodies, customer, or otherwise for facility, QMS, process control, and product compliance by providing on-site walk throughs, documentation, reports, data/analysis. Responsible to report out findings, issue corrective actions, validate root cause analysis, and hold stakeholders accountable to meet the deadlines required by any 3rd party auditor. Receives and reviews all customer satisfaction surveys and customer contacts and complaints. Reviews complaint trends and product/component failure analysis; reviews corrective actions with appropriate personnel. Conducts Management Review with the leadership team and reports out to executive management as agreed to by the President. Assures quality products and processes by establishing and enforcing quality standards and testing materials and products. Develops raw material standards by studying manufacturing and engineering requirements, conferring and negotiating with suppliers, and devising testing methods and procedures. Implements in-process product inspection standards by studying manufacturing methods and devising testing methods and procedures. Establishes standards for the disposition of finished product by devising evaluation tests, methods, and procedures. Institutes rework standards by devising inspection and physical testing methods and procedures. Creates product quality documentation system by writing and updating quality assurance procedures. Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods. Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends. Ensure proper procedures are in place for managing any product, ingredient or packaging material 'HOLDS' or other potential non-conformities, including all documentation and reporting Monitors the technical performance of all equipment against the QMS to verify process controls Conducts necessary validations for processes, procedures, or new equipment as required. Ensures personal safety, food safety, and quality protocols are followed, especially with a focus on adherence to Good Manufacturing Practice (GMP) and Personal Protective Equipment (PPE) protocols and Sanitation Standard Operating Procedures (SSOPs) Develops and manages a quality assurance staff by recruiting, training, and coaching Other duties assigned by the Supervisor/Manager   Position Senior Director of Quality Assurance & Regulatory Affairs   Position Requirements Qualifications: Bachelor’s degree in science, quality, manufacturing, or related fields. Master’s or Ph.D. preferred. Must be 21 years of age HACCP certificate preferred Experience with QMS requirements with FDA and SQF 5-10 years experience as a QA Director (or equivalent) Knowledge of safety requirements and legal standards Strong leadership, analytic and collaboration skill Experience in a food and beverage manufacturing and/or product packaging preferred Proficiency with advanced testing equipment and instrumentation preferred Must be highly computer literate with capability in email, MS Office, and related business and communication tools Collect, interpret, and/or analyze complex data and information Excellent written and verbal communication skills Great attention to detail, essential problem-solving methods and initiative. Advanced ability to learn and apply policies, procedures, standards and guidelines. Ability to work as part of a team and interact effectively with others. Work in a fast paced environment and accomplish multiple tasks within established timeframes. Must be able to read, recognize and speak the English language Must be able to work overtime when needed Key Competencies: Quality assurance knowledge – extensive familiarity with quality assurance processes and procedures, and be able to devise methods to enforce quality standards Team leadership skills – effective team leadership is key in this role - the director of quality manages quality assurance teams and directs their activities Communication skills – possess strong written and verbal communication skills in order to develop manuals and communicate across departments Problem-solving skills – effective problem-solving is essential in this role – accurately access quality issues and develop functional solutions Process management and enhancement – identify opportunities to improve departmental processes and procedures to increase efficiency and effectiveness Financial management – oversee the department budget, make recommendations for change to improve efficiency within the department Working Conditions: Must be able to stand/walk for up to 12 hours, and be able to frequently push, pull, squat, bend, and reach Must be able to use hands and fingers to control equipment for forms of communication by grasping, reaching, and using finger dexterity. Must be able, with or without reasonable accommodation, be able to lift up to 50 pounds depending on job task Must be able, with or without reasonable accommodation, be able to operate carts, dollies, and hand trucks of up to 100 lbs. Must be able to climb and descend stairs safely, with or without reasonable accommodation, and work on a secure mezzanine at a height of up to 25 feet Must be able to work in cool conditions in the winter and warm conditions in the summer   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   This position is currently not accepting applications. To search for an open position, please go to http://BlueMarbleCocktailsInc.appone.com WE ALSO RECOMMEND Other Jobs Within Same Category -- None found -- Other Jobs Within 60 Miles Facilities and Utilities Technician in Indianapolis, IN Posted on: 11/23/2021 [Apply Now] Maintenance Planner in Indianapolis, IN Posted on: 1/24/2022 [Apply Now] Maintenance Technician - 2nd Shift in Indianapolis, IN Posted on: 1/26/2022 [Apply Now] Food Beverage Scientist in Indianapolis, IN Posted on: 2/24/2022 [Apply Now] Sanitation Technician in Indianapolis, IN Posted on: 4/28/2022 [Apply Now] Follow us See who works here:

 

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