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Mgr., Quality Assurance (i)

  • Permanent
  • Anywhere

Website The Bountiful Company

The Bountiful Company

Company : The Bountiful Company

Country: United States

Location : Bayport, New York

Post: Thu, 08 Sep 2022 20:25:56 GMT

Expires: Thu, 06 Oct 2022 23:59:59 GMT

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—————————— Job Description ——————————

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.

Qualifications

5+ years in the food, dietary supplement, medical device or pharmaceutical experience.
Knowledge of FDA regulations for the cGMP of Dietary Supplements and Foods
Experience with Food Safety plans/HACCP, GFSI is a plus
Experience managing teams.
Bachelor’s degree in Pharmaceutical, Food Science, Chemical Engineering, Chemistry or other Science related field and / or previous experience in a quality leadership role preferably within a manufacturing environment or other closely related discipline with extensive significant experience.
HACCP certification preferred
ASQ CQE or CQM preferred
Excellent communication and interpersonal skills, being very detailed oriented
Ability to lead, train, motivate, and work within a team
Good planning and organizational skills
Proven ability to manage of Quality Systems.
Knowledge of regulatory and GMP compliance requirements such as 21 CFR Part 111, HACCP, HARPC preferred
Knowledge of Quality Management Systems e.g. CAPA, Product defense, Pest Control.
Knowledge of auditing techniques and quality toolkit – problem solving, basic statistics, investigations, corrective/ preventive actions
SQF practitioner / FSSC/ BRC/ ISO experience preferred
Must be proficient with PC programs, i.e. Microsoft Office (Word, Excel, PowerPoint)
AS400 Knowledge desirable
Must exhibit exemplary behaviors in line with NBTY Inc. principles and values
Exhibit positive attitude regarding work and responsibilities
Ability to work collaboratively within teams
Ability to maintain effectiveness during major changes in work tasks or the work environment; adjusting effectively to within new work structures, processes, requirements or cultures
Continuously look for ways to do things faster and better, while maintaining high quality standards
Is creative and intellectually curious; tries different and novel ways to solve obstacles
Work weeks are 5 days, Monday to Friday, 8 – 10 hours per day, starting at variable times as needed to cover three shifts of operation. Some weekend work may be required, schedule dependent.
Limited travel required for this role, 10% or less
This role is expected to manage the duties of other team members, particularly on occasion of holidays and sickness. There may also be ad hoc duties as requested by the business as a whole.

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