Mgr. Quality, Health & Nutrition
Job Location:
Quincy, WA - USA
Yearly Salary:
Posted:
Application Deadline:
Vacancies:
Job Summary
Portfolio Business:Huber Engineered Materials
J.M. Huber Corporation is one of the largest privately held family-owned companies in the United States. Established in 1883 we are a diversified global supplier of specialty and commodity chemicals hydrocolloid solutions engineered wood products and natural resources to customers spanning a wide variety of industries. With approximately $3 billion in sales and 4000 employees worldwide we have a material presence in more than 20 countries.
- Lead site quality programs and ensure compliance with applicable cGMP QMS and regulatory requirements including ICH-Q7 21 CFR 111 and 21 CFR 117.
- Manage day-to-day Quality Assurance and Quality Control activities including laboratory testing documentation review batch record approval and product release decisions.
- Supervise and develop Quality staff to support operational excellence and compliance objectives.
- Own site document control change control CAPA customer complaints root cause investigations and out-of-specification (OOS) processes.
- Lead customer audits FDA inspections third-party audits and internal quality audits; drive corrective and preventive actions to closure.
- Direct training programs related to cGMP QMS HACCP and quality procedures while maintaining training compliance records.
- Oversee Annual Product Quality Reviews (APQR) environmental monitoring stability programs validation activities and Quality metrics.
- Maintain and execute the Validation Master Plan (VMP) including process cleaning product and system validations.
- Partner with Operations and leadership teams to drive continuous improvement change management and Cost of Poor Quality initiatives.
- Ensure timely issuance of Certificates of Analysis (CoAs) customer documentation and quality-related communications.
- Bachelors degree in Chemistry Food Science Pharmaceutical Sciences or related discipline; advanced degree preferred.
- 710 years of experience in regulated manufacturing environments withpharmaceutical cGMP experience strongly preferred; food nutrition or dietary supplement experience also valued.
- Minimum 4 years of quality leadership or supervisory experience.
- Demonstrated experience leading FDA inspections regulatory audits customer audits and remediation activities.
- Strong knowledge of cGMP requirements validation programs quality systems CAPA change control and risk management.
- Experience with ICH-Q7 21 CFR Part 111 21 CFR Part 117 HACCP and quality management systems.
- Proven ability to lead cross-functional initiatives manage complex investigations and drive continuous improvement.
- Strong analytical project management communication and customer-facing skills.
- Experience in granulation processes is a in Microsoft Office applications; travel up to 15%.
J.M. Huber Corporation complies with all local/state regulations requiring salary range transparency.
Any offered salary is determined based on relevant factors such as an applicants skills performance job responsibilities prior relevant experience certain degrees and certifications and market considerations.
U.S. Market-Based Salary Range | |
Mgr.-Quality Health & Nutrition | $96900.00 -$125800.00 |
In addition to base compensation individuals may be eligible for an annual discretionary bonus and profit-sharing payout.
Huber also offers a comprehensive competitivebenefitspackage as detailed on the Huber Benefits Hub
Our employees are our strongest asset and their safety health and well-being is our highest priority. We respect the individual by providing opportunities for professional and personal development. Our Principles drive us to create an inclusive workplace where employees share core values show dignity and respect toward others and work hard to achieve their best performance.
J.M. Huber Corporation is an EEO employer. Pre-employment drug screening is required
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Required Experience:
Manager
About Company
Huber is a Portfolio Management Company providing industrial products & engineered materials solutions. Explore the products we bring to your everyday life.
