Quality Assurance Manager

At Pharmatech, we prioritize customer satisfaction as the foremost manufacturer of nutritional products, fostering a culture centered on diversity and inclusion. We are committed to transparency and honesty, striving for the well-being of our teams, customers, and community. With competitive compensation and benefits, along with opportunities for continuous growth in a supportive environment, Pharmatech invites individuals who align with our values to apply.

As the Quality Assurance Manager, you will lead aspects of the quality organization, including training and technical guidance for staff to help maintain an effective, consistent quality system and a safe working environment which meet Pharmatech's priorities.

RESPONSIBILITIES

• Define, implement, and maintain quality assurance objectives that correspond to company policies and goals.
• Develop, train, evaluate and manage Quality Assurance team members.
• Train staff on procedures for compliance of GMP, food and quality safety
• Maintain all Food Safety and Quality certifications
• Assist with third-party and customer audits
• Provide guidance in interpreting governmental regulations and internal policies to assure compliance and serve as liaison between the company and the various governmental agencies such as the FDA and Department of Health during site inspections
• Maintain compliance with product specifications, labeling, and regulatory standards
• Support and assist in corrective action and continuous improvement programs
• Manage, plan, and coordinate quality programs designed to ensure continuous production consistent with established standards.
• Review and update SOPs, policies, and processes regularly to ensure all quality standards comply with GMP standards.
• Support master manufacturing record creation, batch record review, and product release
• Participate in material review and evaluate recommendations for product disposition
• Support change control process to ensure key GMP documents such as product specifications and analytical methods are appropriately controlled.
• Communicate effectively with internal and external customers.
• Other duties as assigned

WORKING RELATIONSHIP

• Reports to the Quality Director
• Works alongside Quality Control, Sanitation personnel, and Production management to ensure policies and procedures are maintained.
• Partners directly with all departments to ensure compliance to quality standards and regulatory requirements.
• Strives to continuously build knowledge and skills and shares expertise with others.

QUALIFICATIONS REQUIRED

• Minimum of 3 years of experience in a quality capacity
• Supervisory or management experience preferred
• Experience in dietary supplement and/or food manufacturing is preferred
• Experience in customer, regulatory, and certification audits preferred
• Experience in NSF, SQF and GFSI preferred
• Understanding of regulatory requirements; reference 21 CFR Parts 110, 111, and 117
• Experience in generating and maintaining SOP's and forms
• Excellent interpersonal skills - team player
• Good verbal and written communication skills
• Bilingual skills (Spanish/English) highly preferred

EDUCATION

• Minimum of a Bachelor of Science degree or commensurate experience