POSITION SUMMARY:

The Quality Assurance (QA) Manager is responsible for ensuring all quality, compliance, and regulatory standards are met per company goals and expectations. The position is also responsible for assuring consistent quality of products by developing, enforcing and monitoring Good Manufacturing Practice (GMP) systems and other quality assurance programs. The QA Manager will be responsible for oversight of the Document Control Department and ensuring personnel are trained to properly complete manufacturing documentation. This role is also responsible for continuous quality improvement, facilitating best practices within the organization, and daily oversight of all activities and personnel within the Quality Assurance Group.
The position reports to the Vice-President of Quality Systems & Regulatory Compliance Department.

REQUIRED EDUCATION / WORK EXPERIENCE / SKILLS:

• At least a Bachelor’s degree, preferably in Food Science or other academic field directly related and essential to the job, or
• Five years of uninterrupted work experience in a quality assurance environment engaged in manufacturing foods or beverages, dietary supplements, pharmaceutical products or personal care products, with at least one year in management capacity.
• Good knowledge of 21 CFR Part 110, 21 CFR Part 210 and 21 CFR Part 117 Good Manufacturing Practices, Hazard Analysis and Critical Control Points (HACCP), Hazard Analysis and Risk-Based Prevention Controls (HARPC), and other food safety programs (Food Defense, Pest Control, Allergen Control, etc.).
• Certification in a food safety-related program (e.g. HACCP, SQF, PCQI, etc.) and/or quality-related program (e.g. ISO) is a plus.
• Ability to analyze processes for biological, chemical, and physical hazards with a thorough understanding of the science and support behind each type of hazard and each step within a process.
• Ability to work with employees at all levels and to motivate direct reports; specifically, mentoring and coaching individuals and identifying short-and long-term development needs and providing appropriate support.
• Ability to manage multiple priorities at one time using effective organizational skills and judgment in an environment of frequently changing circumstances.
• Team player, able to communicate effectively in writing and verbally with employees at all levels of the organization.
• Ability to use Microsoft Office Suite applications; specifically using Word to create and modify documents, Excel to record data and calculate results, and Outlook to communicate internally and externally.
• Ability to use Master Control Suite applications; for all QMS activities related to, document control, Customer Complaints, Non-Conformance. Deviations, Quality Events, Training, reporting, Audit, Mx Production Records…etc.
• Ability to work independently yet interact with many different facets within the company.
• Must be self-motivated, responsible and result-oriented and show flexibility in dealing with changing situations.

OTHER REQUIREMENTS:

• Ability to work extended work hours and weekends when required.

• Formulate, direct, and participate in the development and implementation of goals, objectives, policies and procedures for the Quality Assurance Group.
• Ensure compliance with FDA and various other regulatory requirements by being involved in daily oversight of current Good Manufacturing Practices (cGMPs).
• Maintain the highest level of Good Manufacturing Practices (GMPs) certification and obtain other product safety and quality supporting certifications (e.g. GFSI, SQF certification, Organic Certification, Gluten-Free Certification, etc.).
• In the absence of the Vice-president of Quality Systems: together with the QA Regulatory Manager, serve as the primary liaisons with federal, state, local regulatory agencies and third party during audits, respond to requests for information, coordinate on-site resources, and provide subject matter expertise, ensure proper follow up response and resolution to all regulatory matters. Coordinate and author written responses to the audit report.
• Be a champion for adherence to finished product and customer specifications, GMPs, and other product safety and quality concerns.
• Support product safety plans (including HACCP, HARPC) and perform the function of active team leader.
• Ensure quality assurance programs supporting manufacturing activities to meet appropriate controls and compliance to Good Manufacturing Practices.
• Monitor and audit sanitation processes with regards to their impact on quality and make recommendations of process changes as necessary to meet quality standard.
• Provide leadership, consultation and advice to all departments on issues related to product quality and safety.
• Oversee quality assurance activities: manufacturing quality assurance, SOP system, batch review/release, product and process deviation and non-conformance investigation and resolution, self-audits, etc.
• Manage timely identification, escalation, and resolution of product compliance issues. Alert management of product quality and compliance issues for proper and timely escalation to Material Review Board (MRB).
• Ensure quality events (non-conformances) are thoroughly investigated in a timely manner, driving to true root cause and the identification and implementation of effective corrective action/preventive action (CAPA). Monitor CAPA effectiveness.
• Apply scientific methodology, use of root case analysis and statistical analysis tools to support recommendations for process improvements and drive continuous improvement
• Investigate customer complaints; document complaint, investigation, conclusion and any related recommendations for customer or company actions. Work with customer to fully resolve the issue.
• Audit company policies, procedures, and systems that affect product safety and quality to assure compliance with the company’s quality systems and Good Manufacturing Practices. Prepare documents and reports.
• Conduct and/or evaluate internal audit of all departments and manage the internal GMP audit program that assures compliance and drive continuous improvement of processes, process compliance, and product quality. Ensure timely execution of facility audits and provide the feedback needed to ensure readiness.
• Participate on project teams such as the development of new products or new processes or the installation of new equipment by providing analyses on quality impact and needs.
• Participate in management meetings to update senior management and department managers on quality activities.
• Maintain, revise, author, and update as necessary quality assurance-related policies and procedures (i.e. standard operating procedures) which ensure product safety and quality compliance. Review and approve standard operating procedures from all other departments.
• Prepare, revise, and update specifications for raw materials, packaging components and finished products, Master Manufacturing Records, and other quality-related controlled documents.
• Assure all batch record requirements for product release are met for timely release of all finished products. Manage product release and hold. Manage the release of raw materials, packaging components, and product labels.
• Provide quality assurance support for the review of controlled GMP documentation and ensure that the team of Quality Assurance specialists (Documentation Reviewer, Documents Control Coordinator, etc.) performs thorough and timely reviews.
• Ensure effective implementation and/or utilization of approved analytical methods to ensure the high quality of raw material, in-process products, and finished products.
• Conduct quality and GMP training in various formats to meet the needs of skilled employees and consistently produce employees who are well trained in the skills and requirements for their positions.
• Hire, train, appraise performance, address complaints, and resolve problems arising within the Quality Assurance group. Mentor reporting staff including Quality Assurance Supervisors and Quality Assurance Inspectors.
• Ensure that QA personnel are properly trained on new and/or existing quality procedures and policies, periodically audit personnel for performance, and implement a program or plan to provide cross-training.
• Maintain personal knowledge of current and developing government regulations and industry trends.
• Perform other duties as assigned.
• This position includes responsibility for ensuring Food Safety.
• This position may serve as a backup for Food Safety in the absence of key personnel.