Site Quality Manager

The Site Quality Manager, reporting directly to the Site Director, is responsible for overall accuracy and reliability of test equipment, test results from analysis of raw materials, works in-process and finished products. The position will be determining testing needs and lab budget, including outsourced testing, service contracts, supplies and lab staff scheduling to ensure results are reliable and reported in a timely manner.

The Site Quality Manager will need to effectively communicate the basis and detail of various analytical techniques to meet customer needs including installation, operational and performance qualification validation, troubleshoot results, method feasibility and implementation. This position will be the primary point of contact for site quality relevant audits (ISO9001, FSSC22000, EXCiPACT, etc) and regulatory inspections (FDA, Iowa Department of Inspection and Appeals etc.)

The Site Quality Manager is a leadership position accountable for developing and coaching direct and/or indirect team members. This position will interact with all levels in EDY but is also a part of the EDY Leadership Team.

Wacker is a safety-first organization, and this position will also be critical in maintaining a safe work environment.

Position Responsibilities

EDY Site Analytical Laboratory:

• Ensure production expectations are met (raw material, in-process, and finished goods analysis) while providing customer analytical support (e.g. shelf life or complaint related).
• Oversee maintenance of test equipment
• Responsible for test equipment accuracy and reliability. Oversee the completion or coordination of preventative maintenance tasks at assigned intervals, modify frequency and (as needed) maintain service agreements with relevant providers. Determine external testing needs and select and maintain 3rd party testing agreement, as needed.
• Understand, update, verify/ validate methods and their basis (USP, EP, FCC, and Wacker methods). Ability to provide formal response to customer inquiries regarding methods or results. Train other personnel on methods and document proficiency.

Programs, Certifications and Audits/Inspections:

• Maintain EDY Site quality and HACCP programs and act as lead site preventative controls qualified individual (PCQI); responsible for maintaining and updating regulatory programs (i.e. HACCP programs for FDA regulatory and standard compliance and site Food Safety & Defense plans, with oversight by Regional Quality)
• Update and maintain site HACCP program documents. Oversee or perform quality unit review of production records (monitoring, corrective action and verification) to confirm compliance with FDA, FSSC22000, and EXCiPACT requirements.
• Oversee monthly GMP inspections ensuring compliance; follow up on corrective actions from previous inspections.
• Lead investigations for quality incidents including HACCP deviations, out of spec (OOS) investigations, or when any other activity determines product quality may be impacted. Document containment and corrective actions taken to maintain regulatory compliance. As PCQI, review all necessary documentation as required by regulatory standards.
• Ability to host customer/third party audits and lead regulatory inspections to show conformance with applicable quality standards

Personnel Management:

• Supervision and guidance of the quality analytical lab team ensuring the required and correct level of training for personnel, both safety and job related.
• Advanced leadership competencies which support the rigidity of GMP operations and FDA regulations
• Developing growth plans and opportunities for Quality Team Members

ERP System Duties:

• Maintain data integrity and SAP quality management
• Responsible for performing Quality Manager functions in SAP including evaluating conformance and making usage decisions in SAP while documenting relevant dispositions
• Ensure systems are in place to demonstrate results are accurate, authorized, legible, and data integrity is maintained in accordance with standard and regulatory requirements in 21 CFR Part 11. Oversee and approve OOS investigations.
• Record relevant usage decisions in SAP and document disposition. Troubleshoot missing inspection data, SAP shipping and product availability errors related to testing and inspection.

Additional Duties:

• Lead site investigations of production quality issues and customer complaints to determine cause and corrective/preventive actions. Evaluate current operations for potential improvements. Create concise and accurate investigation or test reports.
• Maintain accurate inventory of items such as product retains, product stability program samples, laboratory chemicals, standards, and solutions. Order lab supplies as needed.
• Schedule and coordinate staffing to ensure efficient lab operation, plan and utilize outsourced testing as needed.

Position Qualifications:

• Minimum of a bachelors degree in a science related field of study (i.e. chemistry, biology, biochemistry etc.)
• 6 years of experience in a food or pharmaceutical environment
• 5+ years in a supervisory or leadership position
• Minimum 15% travel required
• Ability to build an effective safety culture through meaningful discussion with team members
• Good interpersonal skills with proven ability to influence and lead direct reports
• Analytical laboratory experience or knowledge of various techniques, including HPLC/GC, wet chemistry, spectroscopy, and microbiology
• Knowledge of test requirements according to USP and ability to interpret accuracy and precision of results.
• Working knowledge of Quality Management Systems, including ISO9001, and FSSC 22000 (or other GFSI recognized standard).
• Experience performing root cause analysis using a variety of methodologies (i.e 5-why, fishbone, taproot etc.)
• Knowledge and understanding of good laboratory practices, USP requirements for analytical laboratories
• Effective written and oral communication skills (including procedure writing)
• Developed problem solving/ decision making skills
• Certified PCQI
• Knowledge in good manufacturing practices, certified FSSC 22000 or HACCP internal auditor or willingness to be certified.

• 
  
  Compensation and Incentive plans
  
  
• 
  
  Medical, Dental, and Vision Insurance effective day 1
  
  
• 
  
  Paid Time Off in addition to personal days and holidays
  
  
• 
  
  Paid parental leave
  
  
• 
  
  Wellbeing fund
  
  
• 
  
  Flexible hybrid work arrangements
  
  
• 
  
  401(k) with company match
  
  
• 
  
  Education Assistance Program
  
  
• 
  
  Career development and advancement opportunities
  
  
• 
  
  Support for Community Involvement