Job Description
Job Description
At Pharmatech, we make life better! We are committed to building a positive and supportive culture of transparency and honesty, striving for the well-being of our teams, customers, and community. We offer competitive compensation, benefits, and opportunities for continuous growth. Our core values are people, customer service, team, and continuous improvement. If this aligns with your personal core values, please apply to join our team!
Industry: Dietary Supplement Co-Manufacturing
Employment Type: Full-Time, On-Site
Job Summary:
This is a full-time on-site role for a Quality / Documentation Specialist at Pharmatech Labs in Lindon, UT. This is a key role on the Quality Compliance team, responsible for maintaining and improving the Quality Management System (QMS), as well as generating reviewing, and or approving compliance documentation. This is a customer-facing role requiring strong verbal and written communication skills and understanding of regulatory requirements, thereby maintaining the company reputation and customer relationships - providing an unrivaled experience through communication, transparency, collaboration, and improvement.
Employment Type: Full-Time, On-Site
Key Responsibilities Include, but are not limited to:
- Act as a liaison between Pharmatech and the client addressing quality issues and resolutions.
- Lead root cause analysis efforts in response to customer complaints and/or non-conformities (NCRs).
- Ensure that communications with customers are thorough, yet clear and concise.
- Play an active role in identifying opportunities to improve quality processes and systems.
- Support internal audits to ensure compliance with regulatory requirements, company policies, and standard operating procedures.
- Participate in external (regulatory, certification, and customer) audits.
- Work closely with the manufacturing team to ensure quality standards are understood and consistently applied.
- Provide training and support to manufacturing staff on quality standards and best practices.
- Participate and present in regular Material Review Board (MRB) meetings.
- Track and trend the health of the QMS, and present in annual Management Review meeting.
Education & Experience:
- Bachelor’s degree in a relevant field preferred
- Experience in a quality role, in an FDA regulated industry / working in a co-manufacturing or contract manufacturing environment is highly desirable.
Required Skills & Abilities:
- Strong technical writing skills
- Excellent problem-solving and analytical skills
- Detail-oriented with a strong focus on accuracy and compliance
- Effective communication and interpersonal skills to interact with clients and internal teams
- Understanding of quality systems and cGMP / GDP standards
- Familiar with FDA, NSF/NSF Sport, SQF, ISO, 21 CFR 111, and other regulatory requirements preferred
- Ability to manage complex projects with clear priorities in a fast-paced environment
Working Conditions:
- Office and manufacturing environment
- Standard working hours with flexibility to address urgent client needs or quality issues as they arise