Quality Assurance Director

Responsibilities / Tasks

1. Manage QA Laboratory

• Supervise QA personnel and ensure adherence to GEA and OSHA safety protocols.
• Oversee production processes, ensuring manufacturing quality and documentation integrity.
• Maintain and enhance the quality system; develop and assess analytical methods.
• Validate quality processes, establish specifications, and update QA procedures.
• Conduct training, method transfers, audits, and process improvement initiatives.
• Approve deviations, complaints, change controls, and system reports.
• Provide QA laboratory coverage in the absence of technicians.

2. Customer Support

• Facilitate water analysis for clients and interpret data with Promilk specialists.
• Collaborate with Technical Service to address field issues and evaluate complaint samples.

3. Production Support

• Maintain and update manufacturing ticket information for all sites.
• Resolve production issues, assist with distress batches, and oversee returned product rework.
• Work with R&D and production teams on new product transfers and quality checks.

4. R&D Collaboration

• Support new formulation transfers, set specifications, and track initial batch results.
• Evaluate raw materials and develop analytical methods for QA implementation.

5. Regulatory and Global Compliance

• Ensure compliance with global standards, including documentation (COAs, forms, validations).
• Support new product applications in various regulatory environments.
• Provide support for ISO 9001:2015, ISO 14001:2015, and ISO 45001:2018
• Provide support and direction to maintain global quality system to recognized standards
• Maintain compliance with FDA, Health Canada, MAFF and other regulatory agencies

Your Profile / Qualifications

Education:

• Bachelor’s degree in a related science field (Master’s degree in Chemistry with an emphasis on Analytical Sciences preferred).

Experience:

• At least 5 years of laboratory supervisory experience, required in a regulated environment.
• Proven success in dealing with regulatory agencies.
• Strong leadership skills with experience in QA and production environments.

Technical Skills:

• Expertise in quality systems, analytical methods development, and regulatory compliance.
• Proficiency in Microsoft Office (especially Excel) and internet research tools.
• Exceptional problem-solving and cross-functional collaboration abilities.

Soft Skills:

• Strong organizational and communication skills.
• Effective managerial and leadership abilities.

Additional Expertise:

• Experience in global regulatory compliance and standards.
• Familiarity with process improvement initiatives and cross-functional team collaboration.

Working at GEA Group has significant benefits!

• 11 Paid Holidays
• PTO - Paid Time Off
• Medical Plans
• Dental Insurance
• Vision Insurance
• Health Savings and Spending Accounts
• Tuition Reimbursement
• 401k with excellent employer match
• Wellness Incentive Program
• Employee Assistance Program

GEA Group is committed to fostering an inclusive work environment where all clients and employees feel welcomed, accepted and valued. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

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