Quality Assurance Manager

4 weeks ago

Harrisburg, Pennsylvania, United States Inova Health System Full time

Job Summary:

The Quality Manager will lead a team of individuals to ensure effective quality execution, continuous improvement, and regulatory compliance within the facility. This role requires strong leadership skills, with the ability to drive positive change through influence and example.

Key Responsibilities:

  • Manage and lead a team of quality professionals to ensure effective quality execution, continuous improvement, and regulatory compliance.
  • Develop and maintain facility systems and processes that ensure finished product is food safe and meets finished product specifications.
  • Function as a highly organized, effective communicator with an inquisitive mind, capable of investigating and leading solution-based decision making.
  • Ensure daily plant quality and food safety operations are compliant with company policies, procedures, and local, state, and federal regulations.
  • Maintain audit readiness and a robust food safety program.
  • Oversee plant sanitation and ensure the plant pest control programs are current, followed, and utilized to enable proactive maintenance.
  • Manage the facility's change control program to enable robust risk assessment and decisions.
  • Ensure compliance to specification, manufacturing instructions, and preventative maintenance programs.
  • Partner with operations to ensure preventive maintenance programs are robust and adhered to.
  • Collaboratively lead investigations relating to non-conforming events, driving to root cause(s) and effective resolution.
  • Manage hold and release programs.
  • Review records on a daily basis to ensure all records are completed as required and review/approval is current for preventative controls, laboratory, sanitation, production, and verification checks.
  • Foster a positive and effective work culture with direct reports.
  • Identify and retain highly effective personnel through proper selection, training, and expectations.
  • Develop highly effective personnel through proper selection, training, and expectation.
  • Track and report on plant quality key performance indicators (KPIs).
  • Participate in the annual plant budgeting process.
  • Partner with the plant manager on identifying key capital projects that support food safety, Food Safety Modernization Act (FSMA), and regulatory compliance.
  • Provide quality leadership during unplanned events or emergencies.
  • Provide visible leadership by participating in facility walk-throughs and internal audits.
  • Engage and interact with all personnel on a regular basis, assisting them with their challenges and questions concerning food safety.
  • Collaborate with R&D during new/reformulated product introduction to ensure compliance with already established specifications and regulatory requirements.
  • Serve as the point of contact for customer-related issues, complaints, or inquiries.
  • Manage plant complaint investigations, ensuring a thorough, effective, timely, and customer-facing response.
  • Monitor compliance to customer expectations and specifications; communicate any issues/concerns.
  • Maintain plant preparedness for customer and regulatory visits.
  • Be responsible for all analytical and micro activities performed at the facility.
  • Oversee the development of laboratory practices to ensure accurate and precise quality control (QC) results.
  • Perform data analysis to identify critical trends or find leading indicators to enable proactive decisions.
  • Coordinate the collection and evaluation of raw materials and finished products.
  • Ensure the Environmental Monitoring Program (EMP) is robust and risk-based with a search and destroy mentality applied.
  • Determine root cause of failures and take the appropriate corrective action.
  • Escalate nonconformances to quality director and plant manager in a timely fashion.
  • Coordinate and supervise factory and external lab testing of samples; generate Certificate of Analysis (COA's).
  • Maintain the quality management system and ensure documents are up to date and comply to the food safety and quality (FSQ) policies and standards.
  • Prepare plant-specific work instructions as needed.
  • Ensure SSOP documents are robust and adhere to the sanitation standard.
  • Ensure all forms and work instructions are reviewed, revised, and updated annually.
  • Perform management activities such as administering employee promotions and transfers; conducting ongoing performance conversations; mentoring, training, and coaching employees.
  • Follow all company good manufacturing practices (GMP) and work in a manner consistent with all the corporate regulatory, food safety, quality, and sanitation requirements.

Requirements:

  • Undergraduate degree in food science, biological sciences, or related curriculum (or equivalent combination of education and experience).
  • 5 to 8 years of quality assurance or related experience in a food, beverage, or similar facility.
  • Demonstrated attributes, team leadership, or supervisory experience; 1+ year of manager experience preferred.
  • Certification and/or License: PCQI, HACCP, SQF Practitioner certifications preferred; may be required during the course of employment.
  • Strong knowledge of both laboratory and plant current good manufacturing practices (cGMPs).
  • Knowledge of Microsoft Office Suite and company computer systems.
  • Knowledge of principles and practices of supervision, training, and personnel management.
  • Skill in leadership and coaching.
  • Critical thinking, analysis, mathematical calculations, and statistical evaluations.
  • Able to organize and prioritize resources to achieve goals.
  • Able to multi-task; able to keep organized records; able to work with accuracy and attention to detail.
  • Able to translate accounting, financial, and KPI data into plant performance and determine steps to correct and improve.
  • Able to communicate clearly and effectively, both verbally and in writing, for a diverse range of internal and external audiences.
  • Able to work in collaboration effectively and foster good teamwork.
  • Able to take appropriate steps to find solutions to complex problems.
  • Able to present options and ideas to current processes or procedures.
  • Able to handle challenging or conflict situations with tact and professionalism.
  • Able to respond courteously and efficiently to inquiries, complaints, and requests.
  • Able to interpret and apply company policies.
  • Able to adapt and manage to change effectively.
  • Must be able to read, write, and speak English.

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