QA Supervisor

NOW Health Group•Bloomingdale, IL

8d•Onsite

About The Position

The QA Supervisor will supervise the team responsible for creating, revising, maintaining, distributing, and filing controlled documents. This role involves developing, designing, writing, and approving Standard Operating Procedures (SOPs), Laboratory Method Standard Operating Procedures (SOPs), and Master Manufacturing Records (MMRs) to ensure compliance with company policies and regulatory requirements. The supervisor will lead and coordinate cross-functional teams, utilize the EtQ document management system, create and deliver quality tools and training materials, and conduct cGMP and on-the-job training. Responsibilities also include performing Oracle functions, managing documentation flow during audits, reviewing and approving product specifications and COAs, investigating data gathering efficiencies, ensuring document control system compliance, and overseeing training curriculum development. The role requires understanding and communicating GMP regulations and SQF requirements, planning and delivering various learning solutions, and working with managers to identify training needs. The QA Supervisor will also be responsible for safety in their area, including job safety analyses, inspections, employee training, incident investigations, and enforcing company policies and safe work practices. Supervisory duties include interviewing, hiring, training, planning, assigning work, appraising performance, rewarding/disciplining employees, and resolving problems.

Requirements

Bachelor's Degree (BS or BA) in a science (i.e., Microbiology, Chemistry, Biology) and a minimum of five (5) years’ experience in Quality Assurance or Quality Control (preferably in the dietary supplement, food, or pharmaceutical industries) or an equivalent combination of education and experience.
Minimum of three (3) years’ experience in supervision of Quality Assurance or Quality Control staff, change control procedures, and GMP compliance and enforcement is required.
Working knowledge of GMP required.
Excellent working knowledge of cGMP requirements on FDA, 21 CFR Part 111 and 117 Dietary Supplements and Food regulations.
Proficiency in MS Office applications (I.e. Word, Excel) and electronic document management.
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.
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.
Leads Change and Innovation – Challenges the status quo, embraces technology and process improvements, gathers ideas of others, high level of adaptability.
Provides Clear Direction – Plans and organizes well, multi-task abilities, stays focused on priorities, visualizes and plans for the future, understands the industry and marketplace.
Coaches and Develops Others – Builds teams, develops and cares about team members, values and manages diversity, and provides candid and constructive feedback.
Communicates Proactively and Effectively – 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, provides feedback, articulates clearly, and actively listens.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
Ability to write reports, business correspondence, standard operating procedures, and procedure manuals.
Ability to effectively present information and respond to questions from company management and outside agencies.
Customer-Driven – Servant-minded leader in which excellent service is provided. Servant-minded leader who provides excellent service to all customers, sees business through the eyes of the customer, and acts with the customer in mind.
Executes with Excellence – Self-driven, action-oriented, drives for results and motivated to accomplish objectives in a fast-paced environment. Able to handle multiple, complex projects and work independently. Displays a sense of urgency to meet all business objectives. Sets clear expectations and acts decisively. Strong decision-making and ability to problem-solve complex issues.
Flexibility – Ability to prioritize and to shift directions as business needs require. Maintains a positive attitude and high-quality workload. Must be able to work a flexible schedule, including off shifts and weekends.
Ability to organize workload, projects, and documents to assist in accessing information.
Leads through Positive Influence – Ability to coach, mentor and train less experienced staff. Ability to lead the work of others. Demonstrates strong character, builds partnerships, takes personal responsibility for developments, and acts as a role model to others.
Problem-Solving – Reacts quickly and appropriately to opportunities and problems and makes sound decisions. Follows up in a timely manner on issues not immediately resolved. Strong analytical skills to troubleshoot and resolve issues while driving towards root cause analysis. Ability to demonstrate system compliance to a regulatory auditor.
Servant Leadership - Exceptional capacity for managing and leading people. Assumes hands-on participation when needed. Ability to connect with 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.
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, and involves others to accomplish individual and team goals.

Responsibilities

Supervises the team that creates, revises, maintains, distributes, and files controlled documents.
Develops, designs, writes, and, when appropriate, approves Standard Operating Procedures (SOPs), Laboratory Method Standard Operating Procedures (SOPs), and Master Manufacturing Records (MMRs), ensuring compliance with the company’s policies and regulatory requirements.
Leads and coordinates cross-functional teams to facilitate and support revisions to the Standard Operating Procedures (SOPs) and Master Manufacturing Records (MMRs).
Utilizes the EtQ document management system for everyday operations, maintenance, and quality control.
Creates quality tools and training materials by applying body of knowledge expertise and delivers developed content and training to respective teams.
Conducts cGMP and on-the-job training of department personnel.
Comprehends and performs Oracle functions, including but not limited to: specification creation/revision, investigation applications in Oracle (Lot Genealogy, Transaction Inquiry, Lot Sub/Lot, Results, Sample Creation, and Discoverer Reports).
Ensures appropriate group members are trained.
Coordinates flow of documentation during internal and external audits.
Reviews and approves product specifications, COA creation, and master data in LIMS.
Investigates more efficient ways to gather and generate data to improve efficiencies.
Ensures document control systems comply with regulatory requirements.
Understands and communicates GMP regulations and SQF requirements and facilitates processes that support those regulations.
Oversees the development and creation of training curriculum for all components of NOW’s training programs.
Plans and delivers solutions of virtual interactive learning, instructor-led learning, microlearning, blended learning, action learning, game-based learning, and self-learning.
Leverages existing learning platforms, develop curriculums for professional development, while ensuring that our company’s core values are infused in all learning programs.
Works with managers and supervisors to identify training needs.
Collects data, assesses alternatives, and makes decisions regarding training needs.
With subject matter experts, plans and facilitates the training of staff on role-based workflows and processes and delivers in-person or virtual video conference trainings for remote locations.
Hosts train-the-trainer sessions for internal subject matter experts.
Outlines, creates, writes, and edits new and existing standard operating procedures, work instructions, forms, training guides, and training presentations.
Assists with the facilitation of training materials such as work instructions, one-point lessons, training videos, procedure manuals, etc.
Delivers various types of training to employees, including classroom, on the job, virtual, and online training to optimize training effectiveness when needed.
Coordinates, develops, schedules, and/or provides training for SOPs, work instructions, forms, processes, etc.
Complies with safety and GMP requirements.
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.
Supervises employees in BLM Document Control, Label Room, and QA Private Label at Sparks, and on an as-needed basis.
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; and addressing complaints and resolving problems.