Quality Assurance Specialist

Job Summary

Ourvita is the largest Europe-based CDMO for food supplements, with a strong global presence. Backed by over 3,000 dedicated professionals worldwide, we pride ourselves on a customer-centric approach and a culture built on expertise, resilience, service quality, and consumer insight working together to create innovative and impactful solutions. Our vision is to make high-quality health and medical products accessible whenever and wherever they are needed, transforming lives and advancing healthcare globally. Through our commitment to development, distribution, and strategic partnerships, we strive to deliver excellence across the entire value chain. We are currently seeking a skilled and experienced Quality Assurance Specialist to join our team and contribute to this mission.

Responsible for ensuring operational adherence and compliance to Quality Management System (QMS) requirements. This role will be expected to provide input on, and contribute to, the implementation of Quality System improvement strategies and approaches. Key areas of focus include support of the organization?s quality management system, providing support for third party quality certifications (e.g. ASQ 455-2, GFSI/SQF, Kosher, Halal, GFCO, etc.), support of internal / external audits, document control, and regulatory compliance. Provides support to Quality Control, Supply Chain and Production departments.

Your responsibilities will include:

• Support for CAPA system administration, tracking individual CAPAs, and, as necessary, performing work on individual CAPAs.
• Participate in the Food Safety team
• Review and offer direction on the HACCP plans including meeting with Food Safety team and making changes as needed.
• Perform investigation/analysis of returned/complaint materials.
• Perform Manufacturing investigations according to company and client requirements.
• Review Standard Operating Procedures (SOPs) in relation to manufacturing and engineering functions. Make recommendations for changes as necessary.
• Maintain returned goods program and approve product destruction notices.
• Knowledge of ID, traceability, containment requirements, Material Disposition process.
• Participate in Quality Management System initiatives and continuous improvement activities.
• Assist in development of training on multiple quality initiatives and requirements including Good Manufacturing Practices (GMP), Gluten Free, new hire orientation, etc.
• Support Qualification activities and maintenance of the Approved Supplier List. Support management of Supplier/vendor Corrective Actions (SCAR).
• Support site customer-requested auditing activities (Customer and Regulatory Agencies).
• Support Preventive Maintenance, Calibration & Metrology.
• Support generation of Quality Plans for the QMS and Organizational Objectives projects.
• Measure and report quality system metrics providing statistical data/trending analysis, etc.
• Provide support for generation, tracking/trending & reporting of quality system metrics, as required.
• Ensure compliance of all site personnel to QMS requirements.
• Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
• Perform Internal Audits and walkthroughs of the manufacturing facility, reporting findings to responsible parties.
  

Other Duties and Responsibilities:

Understand and adhere to Good Manufacturing Practices.

Safety Protocol:

• Stop any observed unsafe acts and obey facility safety rules and procedures.
• Correct or report any observed safety hazards.
• Support safety policies and programs.

This list of duties and responsibilities is not all-inclusive and may be expanded to include other duties and responsibilities, as deemed necessary from time to time.

Qualifications:

Education / Experience / Certifications:

• Bachelor?s degree in chemistry, biology, or food science preferred.
• Two to four years of experience in food, packaging or dietary supplement manufacturing preferred.
• Equivalent combination of education and/or experience may be considered.
• Must have working knowledge of Quality Systems Management and/or equivalent document management system.
• Quality certification(s) (e.g., ASQ CQA, HACCP, PCQI.) preferred.
• Experience with SQF, NSF, Kosher, Halal, GFCO
  

Skills Required:

• Capable of interaction at all levels of the organization
• Knowledge of selection and testing methodology to define and collect data to support accuracy, reliability, and capability for purpose of measurement and test equipment.
• Knowledge and experience with external standards especially pertaining to product development, design controls, good manufacturing practices, supplier qualification, auditing, quality control (GD&T, Nonconforming Materials, MRB), Corrective and Preventive Actions, and customer complaints.
• Excellent verbal and writing skills using the English language.
• Must be fluent in use of computer systems and database management, specifically Microsoft Office.
• Technical degree, training or equivalent in experience in computer use and software-Microsoft Word, Excel, and Power Point.
• Must be able to read, write and speak fluent English.
  

At Ourvita, we are committed to providing our employees with a supportive and engaging work environment that fosters growth and development. We offer competitive market pay, annual bonus, and a benefits package including:

• Medical, Dental, and Vision coverage
• Basic Life, Accidental Death and Dismemberment (AD&D), Short Term Disability (STD) at no cost to employees
• Retirement Plan 401(k) match
• Holiday pay and Paid Time Off (PTO)
• Opportunities for advancement
• Fitness discounts
• Tuition Reimbursement

If you are a motivated and skilled Quality Assurance Specialist with a passion for excellence, we encourage you to apply today and join our dynamic team at Ourvita.

How to Apply

Interested candidates should submit their application online using the link below.