Quality Assurance Manager I - 1st Shift

NOW Health Group INC•Bloomingdale, IL

4d•$104,600 - $138,500

About The Position

The Quality Assurance Manager I leads and evaluates Quality Assurance personnel and directs quality programs intended to prevent internal failures, improve production performance, reduce product holds and customer complaints, and ensure regulatory compliance. The role implements and maintains a comprehensive Quality Management System covering quality control and inspection, non-conformance tracking, risk assessment, problem and failure reporting, and validation of processes, equipment, and software. It also manages cGMP implementation and maintenance. The position may be based at NOW Health Group’s 395 manufacturing facility or at the Knollwood Corporate office. The scope of responsibilities depends on the location. At the manufacturing location, the manager oversees production-facility QA activities such as document control, training, compliance, quality engineering, specifications, audits, and quality-system improvement. At the corporate office, the manager oversees areas including supplier quality, customer complaints, corporate and international compliance, contract manufacturing support, and related personnel and workflows. The manager supervises QA employees and is responsible for hiring, training, assigning and directing work, evaluating performance, and addressing employee concerns. The role supports a safe production culture and requires compliance with safety practices and GMP requirements. Work may involve production floors and contract manufacturer sites, exposure to noise, chemicals, biological materials, airborne particles, food allergens, and other production conditions, as well as 15–25% travel.

Requirements

Bachelor’s degree in a science field, such as Chemistry or Biology, and at least five years of related Quality Assurance experience in a regulated industry, or relevant experience.
Experience in a cGMP manufacturing environment is required.
Experience in internal and external auditing, change-control procedures, and GMP compliance and enforcement is required.
Working knowledge of GMPs is required.
Ability to read, analyze, and interpret business and technical materials, professional journals, procedures, and governmental regulations.
Strong report-writing, business correspondence, and procedure-manual writing skills, and ability to present information and respond to questions from managers, clients, customers, vendors, officials, and the public.
Ability to work with mathematical concepts such as probability and statistical inference and apply fractions, percentages, ratios, and proportions.
Intermediate to advanced skills in Microsoft Outlook, Word, Excel, and PowerPoint.
Ability to work extended hours, including off shifts and weekends, to support business needs.
Strong leadership, coaching, communication, customer-service, flexibility, change-management, problem-solving, teamwork, strategic-thinking, organization, and time-management abilities.
Ability to work safely and comply with safety policies, procedures, SOPs, and GMP requirements.
Ability to meet the physical demands of desk and computer work, occasional facility walking and stair use, and handling and inspecting materials.
Ability to work in production-floor and contract-manufacturer environments, including areas that may be loud or involve chemicals, biological materials, vapors, airborne particles, herbal aromas, and major food allergens.
Ability to travel 15–25%, including by plane, as required.

Nice To Haves

Master’s degree.
Experience in dietary supplement, food, or pharmaceutical manufacturing.

Responsibilities

Direct, coordinate, evaluate, and mentor Quality Assurance staff and manage employees in the QA department.
Manage QA activities for production facilities, including document control, training, compliance, quality engineering, supplier quality, customer complaints, corporate compliance, and international compliance, depending on assigned location.
Develop, create, revise, and approve raw material, in-process, finished product, and packaging component specifications; develop and maintain SOPs.
Review and qualify new materials and vendors, and supervise specification creation and revision for products and raw materials.
Oversee vendor, customer, site, and other audits, and maintain production-facility audit certifications.
Manage training programs, including new-hire orientation and on-the-job training.
Assist with writing, reviewing, and approving SOPs and Master Manufacturing Records to ensure compliance with company policies and FDA regulations.
Monitor production audits, including checks of code dates, scales, specifications, plant GMPs, and documentation.
Implement quality and process improvement initiatives with quality and operations personnel and maintain product quality through audits and collaboration on product, engineering, manufacturing, and training methods.
Ensure quality-area key performance indicators are met or exceeded and measure productivity against standards.
Support quality-system deviations, CAPA, change control, environmental monitoring, lot release, investigations, and continuous improvement.
Review and approve equipment, process, and software validations as needed.
Ensure quality systems and prerequisite programs comply with regulatory requirements and GMPs.
Create and revise written justifications for procedures related to cGMP compliance.
Communicate GFSI standard updates and FDA FSMA requirements and trends to senior management and, as applicable, suppliers.
Ensure product complaints are logged, investigated, and resolved within established deadlines and company and cGMP requirements.
Oversee formal reports and adverse-event complaint responses to regulatory authorities and detailed complaint trend-analysis reports.
Develop processes for reviewing and implementing new compliance regulations.
Prepare annual budgets, estimate requirements, and schedule expenditures to meet financial objectives.
Support CMO onboarding and implement and oversee supplier and contract manufacturer/contract packer management programs.
Partner with R&D and Procurement on supplier and facility qualification, recommend qualification or disqualification actions, and support supplier selection and approval for new and existing products.
Develop processes and procedures for a risk-based supplier management program.
Manage QA Contract Manufacturing and Business Unit Support workloads, including master formulas, specifications, documentation, manufacturing and batch-record reviews, SCAR approvals, testing method agreements, quality agreements, audits, and follow-up on quality issues.
Manage personnel who interact with contract manufacturers and customers, including those supporting customers when NOW Foods is the contract manufacturer.
Manage requests from the International Group and ensure timely completion.
Work extended hours, off shifts, or weekends as business needs require.
Promote safe work practices, ensure job safety analyses, inspections, and employee training are completed, report and investigate incidents, document corrective and preventive actions, and enforce safety policies and procedures.
Perform supervisory duties including interviewing, hiring, training, planning and assigning work, appraising performance, rewarding and disciplining employees, and resolving complaints and problems.