Summary/Objective - Plan, direct, or coordinate quality assurance programs and SQF. Formulate quality control policies and production efforts. Ensure compliance with regulations and standard operating procedures by planning and coordinating with production on processes.
- Maintain standard in compliance of FDA/GMP/SQF regulations.
- Stay up to date with the latest changes and standards with FDA/SQF/GMP.
- Collect and analyze production samples to evaluate quality.
- Analyze quality control test results and provide feedback and interpretation to production management or staff.
- Work with VP of Manufacturing and Production Director to stop production if serious product defects are present.
- Monitor performance of quality control systems to ensure effectiveness and efficiency.
- Communicate quality control information to all relevant organizational departments, outside vendors, or contractors.
- Instruct staff in quality control and analytical procedures.
- Produce reports regarding nonconformance of products or processes, daily production quality, root cause analyses, or quality trends.
- Participate in the development of product specifications.
- Review statistical studies, technological advances, or regulatory standards and trends to stay abreast of issues in the field of quality control.
- Identify critical points in the manufacturing process and specify sampling procedures to be used at these points.
- Create and implement inspection and testing criteria or procedures.
- Oversee workers including SQF, inspectors, or laboratory workers engaged in testing activities.
- Document testing procedures, methodologies, or criteria.
- Review and update standard operating procedures or quality assurance manuals.
- Identify quality problems or areas for improvement and recommend solutions.
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provide regulatory guidance and communicate to all departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Manage activities such as audits, regulatory agency inspections, or product recalls.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Participate in the development or implementation of clinical trial protocols.
- Maintain trademark/patent applications and IP protection.
1. Must be detail oriented with good time management skill and possess ability to multi-task
2. Must demonstrate excellent math skill
3. Must be able to effectively communicate with every caliber of employee
4. Must demonstrate effective leadership ability with ability to work in a team environment
5. Must demonstrate excellent project management skills
6. Must demonstrate excellent ability to work in ERP systems
7. Must be proficient in all areas of MS Office
8. Strong project management, business writing and reporting skills.
9. Must have strong problem Solving/Analysis ability
10. Must be a strategic thinking
11. Must be customer focused
12. Must be SQF certified with direct experience with AAFCO, food manufacturing
Required Education and Experience
- Must have a BA in Food Engineering or Food Science
- 2+ years’ in Quality/RA or a combination of equivalent.
- 2+ years’ experience in a management role required.
- Experience gathering, evaluating, presenting and reporting Quality/RA/SQF information to executive teams and external agencies required.
- Personal qualities of integrity, credibility, and unwavering commitment to NPIC mission; a proactive, hands-on strategic thinker who will own, in partnership with the R&D Director, the responsibility for Quality/RA/SQF.
- Solid experience coordinating Quality/RA/SQF activities and managing reporting, budget development and analysis.
- Keen analytic, organization and problem solving skills which allows for strategic data interpretation versus simple reporting.
- Strong interpersonal and communication skills; experience in effectively communicating key data, including presentations to senior management, board or other outside partners.
- Ability and desire to translate complex Quality/RA/SQF concepts to individuals at all levels including Quality/RA/SQF and non-Quality/RA/SQF personnel.
Preferred Education and Experience
- Food manufacturing experience preferred but not required
- HACCP Certified
- SQF Certified
This position has the following positions as direct reports:
- Quality Inspectors, Leads, and/or Supervisor
- SQF Specialist
- Data Scientist(s)
- QC Lab Technician(s)
Rapidly growing premium pet treat company located in the Dallas metroplex area.
Posting ID: 593382501Posted: 2021-01-16