What are the responsibilities and job description for the Quality Systems Supervisor position at INW Manufacturing, LLC?
Who we seek: We are currently seeking an experienced Quality Supervisor. We are looking for a positive professional, who is honest, detail-oriented, organized and who takes initiative and pride in their position within the company.
Position Summary: The Quality Systems Supervisor is responsible for all quality activities required for compliance to INW-Phoenix Formulation’s quality management system and compliance with applicable cGMP regulations.
Essential Functions and Responsibilities:
- Assure facility compliance to FDA and regulatory standards, conduct internal and external audits (Customer, Regulatory or Certifying Bodies).
- Evaluate, initiate, and maintain quality management systems.
- Ensure compliance and record keeping for all quality checks, testing, sampling, and other manufacturing activities.
- Responsible for quality activities for documenting any internal non-conformance, customer complaints and out of specification conditions, investigating root cause, corrective actions and making appropriate decisions.
- Contribute to the development of site culture and act as a role model for PF values and behaviors.
- Use continuous improvement methodologies and projects to improve and streamline quality processes.
- Manage and oversee training of Quality staff.
- Ensure that all products meet quality standards and are consistent with customer requirements.
- Develop and ensure staff participation in cGMP training program(s).
- Maintain Environmental Testing Programs.
- Approve CAPAs, and NCRs.
- Program maintenance for Organic, Gluten Free, Kosher, Halal, and SQF certifications.
- Review and approve Master Manufacturing Records (MMRs) and Batch Records in support of quality and operations.
- Coordinate interdepartmental activities with Lab, Supply Chain, Operations, and Sales and Customer to meet business requirements.
- Assist with the development and maintenance of spreadsheets and tracking tools for measuring department objectives and other metrics for trending.
- Maintain regular and punctual attendance at work.
- Perform duties safely and to report unsafe conditions or actions.
- Act as back up to the SQF Practitioner:
- Oversee the development, implementation, review, and maintenance of the SQF System
- Ensure all regulatory requirements are being met
- Take appropriate action to ensure the integrity of the SQF System; and
- Communicate to relevant personnel all information essential to ensure the effective implementation and maintenance of the SQF System.
Minimum Qualifications:
- Extensive knowledge of 21 CFR Good Manufacturing Practices, specifically part 111 and 117.
- 2 Years in a leadership role.
- Minimum of 5 years’ experience working in a Quality function at a food or dietary supplement manufacturing facility.
- Knowledge of Quality management tools, such as Pareto and histogram analysis, statistical process control, regression analysis, and statistical sampling methods.
- Thorough knowledge of audits and auditing procedures.
- Knowledge of analytical testing procedures.
- Detailed knowledge of document and change control procedures.
- Ability to map processes and write effective Standard Operating Procedures.
- Education – degree in Food Science or a Technical field or have equivalent field experience.
- HACCP Certified
Preferred Knowledge, Skills, and Abilities:
- Mathematical Skills – Accuracy with arithmetic, subtraction, multiplication, division, decimals, percentages, fractions, and algebra.
- Communication Skills – Must be able to communicate effectively with all levels of personnel and outside parties with exceptional written and oral communication skills.
- Computer Skills – Must be able to use Microsoft Office, operate inventory software, time keeping or other business-related software.
- Skilled in monitoring, troubleshooting, detailed oriented critical thinking, process control, time management, following through, serving customers, and active listening. Ability to adapt to frequent changes, unexpected events and still yield an effective outcome.
- Demonstrate understanding of regulatory issues, leadership, attention to detail, orientation to quality, deductive reasoning, problem sensitivity, problem solving, and skilled at decision making.
- Knowledge of sanitation requirements for quality assurance and food safety criteria (HACCP), FSPCA PCQI Training, food production processing, chemistry, biology, Food and Dietary Supplement cGMP’s, human resources, and safety of personnel.
- Maintains high level of confidentiality.
Disclaimer: Compensation reflective of candidate’s experience. This job description is only a summary of the typical functions of the job, not an exhaustive or comprehensive list of all possible job responsibilities, tasks, and duties. The responsibilities, tasks, and duties of the jobholder might differ from those outlined in this job description and other duties, as assigned, may be part of the job.
We Offer: Medical, Dental, Vision, Life, 401K, Paid Holiday, Paid Vacation, Paid Sick Leave, and more!
** Offers are contingent on successful completion of drug screen and background check**