Quality Assurance Specialist

The Quality Assurance Specialist is responsible for the management of quality systems to ensure compliance with quality and regulatory requirements and corporate quality standards. The Quality Assurance Specialist works closely with all facility personnel to ensure excellent quality performance and full compliance with cGMP and Food Safety requirements.

• Responsible for enforcing Good Manufacturing Practices and other quality-related policies in order to meet product quality standards.
• Review Production Batch Records and other manufacturing-related documents to verify compliance and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.
• Act as QA reviewer for investigations, deviations, complaints, and CAPAs as designated by QA Management.
• Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.
• Follow up with implemented programs (GMPs, Good Hygiene Practices, HACCP, Allergen. Control, Cleaning and Sanitation, Pest Control, Equipment Calibration, Organic Certification, etc.) to ensure compliance by all employees and other personnel in the manufacturing facility.
• Assist in the coordination of testing results involving finished products, raw materials, and packaging components and the appropriate release and hold programs associated with these materials.
• Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.
• Make proactive recommendations and offering/presenting solutions to the Quality Systems & Regulatory Compliance Department Management to improve quality and work efficiency.
• Share knowledge, skills and information with other personnel in the Quality Systems & Regulatory Compliance Department and across functional areas.
• Identify and participate in internal quality improvement initiatives, perform gap analyses and risk assessments, develop and implement improvements, create and revise relevant SOPs.
• Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.
• Participate in all regulatory, third party and customer audits and inspections, and corrective action response.
• Customer Complaints - Responsible for documenting, investigating, and maintaining customer complaints in complaint systems. Contact customer, lead investigations, determines root cause and corrective/preventive action. Follow up with customer and respond to customer in writing.
• Assist in maintaining Food Safety and Food Defense programs that define requirements to maintain compliance with Food safety standards.
• Internal Auditing: Work with site operations team to develop and execute risk-based audit plans to mitigate quality risk.
• Oversee and coordinate the site's 3rd party Quality audit programs.
• Ensure GMP training is effective in sharing GMP know-how needed to achieve best in class quality operations.
• Work with the site Food Safety committee to accomplish Food Safety objectives and to maintain continued compliance with all requirements. Provide coaching at all levels of the organization.

• Bachelor's Degree in Life Sciences, Pharmacy, Engineering withleast 2 years of work experience in quality assurance in dietary supplements, food/beverage, pharmaceutical or cosmetic industry or an Associate degree with at least 5 years of relevant experience in Quality Assurance.
• A good knowledge of Current Good Manufacturing Practices, preferably 21CFR Part 111, 211, IPEC, ICH Q7, FSSC 2200, and food safety.
• Good understanding of quality testing within the food and beverage, pharmaceutical or cosmetic industry to include analytical and/or microbiological analysis. Must possess a basic understanding of chemical and microbiological analysis and basic math.
• Ability to work under pressure (in an extremely fast paced environment), meet deadlines (overtime work required) and make effective decisions.
• Experience with Root Cause Analysis tools.
• Skill in organization and prioritization, and attention to details.
• Strong team player and leader with the ability to work across multiple functions and disciplines.
• Must be able to effectively communicate ideas (verbally and in writing), be a self-starter and handle difficult reporting situations.
• SAP experience preferred.