Company Description
The Bountiful Company, a Nestlé Health Science Company, is a pure play branded leader in global nutrition, living at the intersection of science and nature. As a manufacturer, marketer and seller of vitamins, minerals, herbal and other specialty supplements, and active nutrition products, we are focused on enhancing the health and wellness of people’s lives. The Bountiful Company’s portfolio of trusted brands includes Nature's Bounty®, Solgar®, Osteo Bi-Flex®, Puritan’s Pride®, Sundown® and Ester-C®.
Inclusion and Diversity in the workplace matters at The Bountiful Company. This includes being focused on retaining and recruiting a diverse workforce and building a culture of inclusivity. Our goal is to create a place where people feel respected, valued and able to bring their authentic selves to work each day.
Did we mention that we also offer excellent benefits, competitive compensation and a progressive, healthy company culture? If you’ve ever spent your workdays watching the clock, you know how important a positive work environment is for a person’s well-being. The Bountiful Company is committed to supporting wellness in all forms. And when it comes to wellness, nature is a pretty good place to start.
Job Description
As the Quality Assurance Manager you are responsible for ensuring the compliance of the quality systems, manufacturing processes and associated records for adherence to The Bountiful Company's Standard Operating Procedures (SOP’s) and Good Manufacturing Practices (cGMP’s) that are in effect within their manufacturing site, assuring the quality of products produced. In this role, you will have the opportunity to lead, train, motivate and develop capabilities to a group of up to team members across multiple shifts.
Additional responsibilities include, but are not limited to:
- Develops staff through feedback, coaching, counseling and support.
- Ensures both new and existing associates are trained on cGMPs as it relates to 21 CFR part 111.
- Maintains compliance with FDA Regulations and other industry accepted standards.
- Supports and participates in audit preparations and inspections by certifying agencies and regulatory bodies, i.e. USP & FDA. Participate in developing action plans and executing corrective actions in a timely manner.
- Leads, anticipates, assesses and manages current and future compliance in the facility.
- Ensures accurate and timely completion of all tasks relating to Batch records and maintenance of cGMP and SOP records.
- Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA). Evaluate data using statistical tools. Lead or actively support Product Change Control.
- Works collaboratively with cross-functional teams to implement necessary production changes, system updates, and documentation revisions in a timely and productive manner.
- Facilitates and properly manages the oracle based PQM (Product Quality Management) including but not limited to; Deviations, Non-Conformances, CAPAs, Change controls.
- Facilitates and presents data and information pertaining to quality performance to upper management.
- Facilitates Material Review Board (MRB) for non-conforming materials, determination and documentation of dispositions of said material.
- Develops cross functional and multinational relationships to support interaction with various internal customers.
- Supports, leads, administers all mock recall activities for the site; is the expert in the area of mock recall, retrieval, and recall.
- Supports the Quality Manager in daily activities and quality system. In addition act as the site lead in the absence of the Quality Manager.
- Demonstrates leadership through a commitment to communication, work habits and be fully competent in all aspects of a wide variety of processes including maintaining safety, troubleshooting/problem solving, decision making, organizing/planning, core behaviors, administrative, quality appraisals, sampling plans, manufacturing audits/process audits, statistical techniques, production control systems, manufacturing document review, test equipment and training.
- Understands SPC and how to leverage data to drive improvements into processes.
- Partners with Operations team and Technical Services group to execute and facilitate site initiatives in pursuit of business objectives and targets.
- Acts as role model of the business vision and mission and have a strong understanding of what it takes to achieve company goals, KPI’s and metrics.
- Supports continuous improvement activities when Quality KPIs are not met.
- Supports management of the HACCP Program for the facility.
- Supports goal setting, administers performance appraisals, and conducts interviews for new candidates.
- Responsible of supporting HPS (High Performance Systems) principles and beliefs.
- Other duties may be assigned as required.