Mgr., Quality Assurance

Job Description

• 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, The Nature’s Bounty Co. 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.

Additional information