QA SUPERVISOR

Responsibilities

• Supervises the team that creates, revises, maintains, distributes, and files controlled documents.
• Develops, designs, writes, and approves Standard Operating Procedures (SOPs), Laboratory Method SOPs, and Master Manufacturing Records (MMRs), ensuring compliance with company policies and regulatory requirements.
• Leads and coordinates cross-functional teams to facilitate and support revisions to SOPs and MMRs.
• Utilizes the EtQ document management system for everyday operations, maintenance, and quality control.
• Creates quality tools and training materials and delivers content and training to respective teams.
• Conducts cGMP and on-the-job training of department personnel.
• Performs Oracle functions, including specification creation/revision, investigation applications (Lot Genealogy, Transaction Inquiry, Lot Sub/Lot, Results, Sample Creation, and Discoverer Reports), and 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, including virtual interactive learning, instructor-led learning, microlearning, blended learning, action learning, game-based learning, and self-learning.
• Works with managers and supervisors to identify training needs, assess alternatives, and make decisions regarding training.
• Plans and facilitates the training of staff on role-based workflows and processes, delivering 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, and procedure manuals.
• Delivers various types of training to employees, including classroom, on-the-job, virtual, and online training.
• Coordinates, develops, schedules, and/or provides training for SOPs, work instructions, forms, and processes.
• Complies with safety and GMP requirements.
• Ensures the completion of job safety analyses, safety inspections, and employee training.
• Acts as primary communicator of safe work practices and information to the department.
• Facilitates employees’ participation in the safety activity card program and on safety teams.
• Completes incident investigation reports and submits them to the manager by the end of the shift on which the incident is reported.
• Conducts safety contacts and documents corrective and preventative actions.
• Enforces company policies, procedures, SOPs, and safe work practices.

Supervisory Responsibilities

• 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, including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.

Requirements

• Bachelor's Degree (BS or BA) in a science (e.g., 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.
• Working knowledge of GMP and excellent working knowledge of cGMP requirements on FDA, 21 CFR Part 111 and 117 Dietary Supplements and Food regulations.
• Proficiency in MS Office applications (e.g., Word, Excel) and electronic document management.

Skills

• Ability to work with mathematical concepts such as probability and statistical inference, and 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, and demonstrates adaptability.
• Provides Clear Direction: Plans and organizes well, multitasks, stays focused on priorities, visualizes and plans for the future, and 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.
• Customer-Driven: 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. Handles multiple, complex projects and works independently.
• Flexibility: Ability to prioritize and 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.
• Leads through Positive Influence: Ability to coach, mentor, and train less experienced staff. Demonstrates strong character, builds partnerships, takes personal responsibility, and acts as a role model.
• Problem-Solving: Reacts quickly and appropriately to opportunities and problems, makes sound decisions, and follows up in a timely manner. Strong analytical skills to troubleshoot and resolve issues while driving towards root cause analysis.
• Servant Leadership: Exceptional capacity for managing and leading people. Assumes hands-on participation when needed. Connects with staff both individually and in large groups, enforces accountability, and maximizes employee development.
• 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 goals.

Physical Demands

The physical demands described here are representative of those required of 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.

• Regularly required to work at a desk and enter information into a computer.
• Frequently required to use a computer and keyboard and to communicate in person and by telephone.
• Required to read/review written documentation for extended periods.
• Specific vision requirements include close vision, peripheral vision, depth perception, and the ability to adjust focus.
• Occasionally required to lift up to 25 lbs., and be able to walk, stand, reach, and stoop.
• Ability to travel, including travel to other company facilities.

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.

• The noise level in the work environment is usually moderate.