Quality Assurance Manager I - 1st Shift

Description

SUMMARY

Manages the overall direction, coordination, and evaluation of QA staff, develops and manages the company’s quality control environments to prevent internal failures. Develops initiatives to improve production performance against established quality measures, resulting in reduced product holds and customer complaints. Manages and mentors Quality Assurance personnel and acts as the primary liaison regarding quality with customers, vendors, and external regulatory agencies. Implements a robust Quality Assurance (QA) program that includes a comprehensive Quality Management System (QMS), quality control and inspection, non-conformance tracking and assessment, risk analysis and assessment, problem/failure reporting, and process/equipment/software validation. Manages cGMP implementation and maintenance in all cGMP-related activities. This position will either work at NOW Health Group’s 395 manufacturing facility or at the Knollwood Corporate office. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Manufacturing Location Responsibilities: Manages all Quality Assurance activities for all production facilities, including, but not limited to, Document Control, Training, Compliance, and Quality Engineering. Develops, creates, revises, and approves raw material, in-process, finished product, and packaging component specifications. Develops and maintains Standard Operating Procedures. Reviews and qualifies new materials and vendors. Manages the compliance team including direct oversight of vendor and customer audits. Manages the training team that oversees New Hire Orientation and manages On-the-Job Training. Assists with the writing, review, and approval of Standard Operating Procedures (SOPs) and Master Manufacturing Records (MMRs), ensuring compliance with the company’s policies and FDA regulations. Assists with monitoring of daily audits of production procedures, including verification of code dates, scales, specifications, plant GMP’s, and documentation. Implements quality and process improvement initiatives in conjunction with quality and operations personnel to ensure products meet quality standards. Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits, collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods. Ensures key performance indicators in the quality area are met or exceeded. Measures productivity on a daily basis, with the goal of meeting standards. Supports quality system deviations, CAPA, change control, environmental monitoring, etc. to support lot release and continuous improvement. Reviews and approves all levels of quality validations (equipment, process, and software), as needed. Assists Senior Management in plant process improvement activities and implementation for Quality systems investigation review and approval. Ensures quality systems comply with regulatory requirements. Ensures pre-requisite programs (pest control, environmental monitoring, etc.) are compliant with GMPs. Creates and revises written justification for procedures in relation to cGMP compliance. Supervises specification creation/revision for all NOW products and raw materials. As needed, accompanies group members on audits or site visits of contract manufacturers, if necessary. Maintains knowledge and communicate GFSI standard updates and FDA FSMA requirements and trends to senior management. Maintains and manages our audit certifications for all production facilities. Complies with safety and GMP requirements. Corporate Office Responsibilities : Manages all Quality Assurance activities for all production facilities, including, but not limited to, Supplier Quality, Customer Complaints, Corporate Compliance, and International Compliance. Ensures product complaints are logged, investigated, and resolved according to established deadlines, company, and cGMP requirements. Manages oversight of formal reports for adverse event complaint responses to regulatory authorities. Ensures management oversight of detailed trend analysis reports showing product complaints by category and product. Ensures key performance indicators in the quality area are met or exceeded. Measures productivity on a daily basis, with goal of meeting standards. Supports quality system deviations, CAPA, change control, etc. to support lot release and continuous improvement. Assists Senior Management in process improvement activities and implementation for Quality systems investigation review and approval. Ensures quality systems comply with regulatory requirements. Develops and implements a process for the quality review and implementation of new compliance regulations. Meets financial objectives by estimating requirements, preparing annual budgets, and scheduling expenditures. Assists in the CMO onboarding process. Implements and oversees an effective supplier and CM/CP management program. Supports the organization in properly qualifying suppliers. Closely partners with the R&D and the Procurement teams to develop an approval process for qualification of new suppliers/facilities. Recommends actions related to supplier qualification / de-qualification. Provides technical and quality knowledge for supplier selection, qualification, and approval. Supports proper selection of purchased product and suppliers for new products and life-cycle management of current product. Assists in the development of processes and procedures to ensure that a risk-based supplier management program is followed. Manages the flow of workload coming into the QA Contract Manufacturing and & Business Unit Support Group. This includes but is not limited to interaction and agreement on Master Formulas, Specifications, Documentation Receipt and Availability, review of Master Manufacturing and Batch Production Records, review and approval of SCAR documentation, and Testing Method Agreements with Contract Manufacturers (CM). In instances where NOW Foods is the CM, includes managing NOW site audits and visits, quality agreements and interaction with customer QA and Sales. Group members also responsible for following up on quality issues. Manages personnel who interact directly with the CM and those personnel who interact with customers of which NOW Food’s is the CM (Business Unit Support). As needed, accompanies group member on audits or site visit of contract manufacturers if necessary and is involved in NOW Food’s audits by customers. Manages the flow of requests by the International Group; follows up with those assigned the task and ensures timely completion. Manages the QA Product Complaint team and ensures that complaint resolution is accomplished according to established deadlines. Maintains knowledge and communicate GFSI standard updates and FDA FSMA requirements and trends to suppliers and senior management. Complies with safety and GMP requirements.

SAFETY RESPONSIBILITY STATEMENT

Supports a culture of safe production and exhibits safe work practices. Actively participates in the safety program by engaging in safety activities. Effectively provides and accepts constructive peer-to-peer feedback on safety performance. Adheres to policies, procedures, SOP’s, safe work practices, and safety policies and procedures (SPP). Reports ALL workplace incidents to manager immediately. Communicates concerns to manager, reports hazards, and provides input on prevention. Properly uses, wears, and stores Personal Protective Equipment when required. Participates on safety teams and/or completes safety-related activities as part of regular job responsibilities. Responsible for safe work performance in area. Ensures the completion of job safety analyses, safety inspections and employee training. Acts as primary communicator of safe work practices and information to department. Facilitates employees’ participation in the safety activity card program and on safety teams. Completes incident investigation reports and submits them to manager by end of shift on which the incident is reported. Conducts safety contacts and documents corrective and preventative actions. Enforces company policies, procedures, SOP’s, SPP’s and safe work practices.

SUPERVISORY RESPONSIBILITIES

Manages employees in the Quality Assurance department. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Bachelor's degree (B. A.) four-year college or university with major in a Science field (i.e. Chemistry, Biology) and minimum five (5) years related experience in Quality Assurance in a regulated industry; or relevant experience. Master’s degree preferred. Experience in a cGMP manufacturing environment, preferably dietary supplements, foods, or pharmaceuticals is required. Experience in internal and external auditing, change control procedures, and GMP compliance and enforcement required. Working knowledge of GMP’s required.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Strong ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations. OTHER SKILLS and ABILITIES Ability to work extended hours, including off shifts and weekends, to support business needs. Intermediate to advanced skill level in Microsoft Outlook, Word, Excel, and PowerPoint.

COMPENTENCIES

Safety Awareness - Considers the impact on safety when making decisions and ensures safety is a top priority. Acts with Integrity – Demonstrates responsible, ethical, and honest behavior and models NOW’s core values. High level of interpersonal skills to handle sensitive and confidential situations and documentation. Communication – Communicates clearly, candidly, directly, and concisely. Keeps others informed and listens carefully to input and feedback. Strong verbal and written communication skills. Approachable, relates well to others, engages people, and helps them understand change. Ability to write reports, business correspondence, technical articles, and procedure manuals. Ability to effectively present information and discuss issues and respond to questions from groups of managers, peers, vendors, and customers. Excellent verbal and written communication skills. Ability to interact with outside vendors and officials and present a professional, positive image at all times. Coaches and Develops Others – Builds teams, develops, and cares about team members, values and manages diversity, provides candid and constructive feedback, delegates appropriately. Customer-Driven – Servant minded leader in which excellent service is provided to all customers, sees business through the eyes of the customer, and acts with the customer in mind. Flexibility – Ability to prioritize and to shift directions as business needs require. Maintains a positive attitude. Learns quickly and assumes responsibility for new tasks in a rapidly growing and changing company. Ability to work off shifts and weekends to support business needs. Leads Change and Innovation – Challenges the status quo, embraces technology and process improvements, gathers ideas of others, high level of adaptability. Problem-Solving – Strong decision making and reasoning skills. Ability to problem solve complex issues. Reacts quickly and appropriately to opportunities and problems. Follows up in a timely manner to issues not immediately resolved. Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Achieves Results through Teamwork – Demonstrated ability to work in a team environment as well as manage projects independently. Open to diverse ideas, works collaboratively, holds self and others accountable, involves others to accomplish individual and team goals. Ability to work with others to complete assigned tasks with a team environment. Servant Leadership - Exceptional capacity for managing and leading people. Assumes hands on participation when needed. Ability to connect staff both on an individual level and in large groups. Capacity to enforce accountability and learn the strengths and weaknesses of the team so as to put people in a position to succeed and to maximize the development of employees. Strategic Vision and Agility - Ability to think strategically, anticipate future consequences and trends, and incorporate them into the business plan. Time Management and Organization – Able to manage multiple, complex projects and work independently. Displays a sense of urgency to meet objectives. Excellent attention to detail and achieves high quality workload. Excellent organization skills and stays focused on priorities.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit at a desk and use computer and phone. The employee is occasionally required to walk throughout the facility; ascend and/or descend stairs; use hands to inspect, handle, and feel; and reach with hands and arms. Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. This position is required to work on the Production floor at NOW Health Group and/or at contract manufacturers: As required, works in a loud area that requires hearing protection and other protective equipment to be worn. Works around ingredients such as vitamins, minerals, amino acids, botanicals, etc. and chemicals such as alcohol, which may require respiratory protection. May be exposed to potentially hazardous chemicals and biological materials. Frequently exposed to vapors, airborne particles, and/or herbal aromas when in a production or sampling environment. Frequently exposed to all of the FDA designated major food allergens (Milk, Eggs, Fish, Crustacean shellfish (e.g. crab, lobster, shrimp), Tree nuts (e.g., almonds, walnuts, pecans), Wheat and Soybeans, except for peanuts). 15-25% travel (including travel by plane) may be required. #J-18808-Ljbffr NOW HEALTH GROUP