What are the responsibilities and job description for the Quality Assurance Manager position at Pharmatech, Inc.?
At Pharmatech, providing an unrivaled customer experience as a nutritional product manufacturer is our vision. We fostering a positive, diverse, accountable and supportive culture centered on integrity and continuous improvement. If this aligns with your values, we invite you to join our team!
The Quality Assurance Manager is a key role in the organization with responsibility to manage a team of inspectors and technicians, ensuring quality, safety, and regulatory compliance throughout the sampling, manufacture, and release processes.
RESPONSIBILITIES
- Effectively manage Quality Assurance team providing training and support as needed
- Train staff on procedures for compliance with cGMP, HACCP, Food Defense, and other important standards.
- Support company and product certifications (NSF, NSF for Sport, Kosher, Non-GMO, Organic, etc.)
- Provide guidance and ensure compliance with FDA and Department of Health
- Participate in internal and external audits (regulatory, certification, and customer)
- Review and update SOPs, policies, and processes regularly to ensure cGMP
- Support team in sampling, in-process verifications, and product release
- Member of the Material Review Board (MRB)
- Participate in aspects of the Quality Management System (QMS)
- Communicate effectively with internal and external customers
- Other duties as assigned
WORKING RELATIONSHIP
- Reports to the Director of Quality
- Actively fosters the Pharmatech culture in word and deed
- Works with Quality Control, Compliance, Sanitation, and Operations teams to affirm policies and procedures
- 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
- Demonstrated success in leadership role (3 years)
- Experience in FDA regulated industry (Dietary Supplement, Food, Medical Device, etc.)
- Understanding of regulatory requirements; reference 21 CFR 110, 111, and 117
- Facility and product certification experience preferred (NSF, TGA, SQF and GFSI)
- PCQI, CQA, and similar certifications preferred
- Excellent interpersonal and communications skill
- Bilingual skills (Spanish/English) preferred
EDUCATION
- Bachelor of Science degree or commensurate experience
