Director of Quality

Company: Elevation Labs
Location: Denver
Posted on: April 23, 2025

Job Description:

About UsWhat do we consider our greatest asset? Our passionate team members.With a vision of creating quality skincare and cosmetic products for the most popular brands in the world, our founders established a company based on the principle of "no surprises." Since 1995, this vision has guided our growth, and we have developed into an organization that pushes the boundaries of formulating and manufacturing. With over 400 full-time employees, we continue to build a highly-engaged team that produces quality products for our customers. We are especially focused on collaboration and continuous improvement; we work together to learn from where we have been and to make where we are going even better.Elevation Labs is proud to offer employees a competitive benefits package including: paid time off, paid holidays, maternity leave, 401k with company match, bonuses, health insurance with a health reimbursement arrangement (HRA), dental and vision plans, life, A&D, short term and long term disability insurance plans and a company-paid employee assistance program (EAP).Our Mission and CulturePhenomenal Customer Experiences every day, through highly Engaged and Empowered Colleagues, while impacting our Community in a progressive way.We believe that the best way to deliver phenomenal customer experiences is to create an environment where our employees feel appreciated and supported. We work to build trust through regular all-hands meetings and approachable leadership. We encourage meaningful relationships and thoughtful interactions between team members at all levels of our organization: our line leads value active engagement on the production floor, and our management team is committed to supporting employee growth and career development. As one of the largest companies in the area, we offer countless ways for you to follow your passion and grow your career.Aside from our company culture, we are committed to making a positive impact within the larger Denver community. Throughout the year our employees host STEM Exposure events at local elementary and middle schools, and we also actively support multiple charities, including the local branches Toys for Tots.Our ValuesAct With Integrity We uphold the highest standard of integrity in all that we do. We honor our commitments and are transparent and honest with our customers, colleagues and communities.Take Ownership We act with discipline and rigor. We hold ourselves accountable to follow the highest standards and deliver our commitments on time.Seek Innovative Solutions We challenge the status quo and seek out innovative ways to improve all that we do, from product formulation to production efficiencies and cultural advancements.Show Care and Respect We deeply care about the health, happiness and safety of our colleagues and communities. We treat others as we want to be treated.Work And Win Together We believe that success depends on collaboration and teamwork. We work tirelessly with our partners, both internal and external, to deliver Phenomenal Experiences Every Day.JOB SUMMARY:Participates, as member of management team, in formulating and establishing a product quality assurance program, standard operating procedures (SOP's), organizational policies, and levels of regulatory compliance for the company.ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develops, implements, and coordinates, through support staff, a product quality assurance program to prevent or eliminate defects in new or existing products including but not limited to incoming raw materials, packaging components, process water, bulk product batches and finished goods.
• Communicates customer product specifications and requirements and suggests and debates alternative methods and procedures in solving problems and meeting changes with these specifications. Develops, implements, revises and audits Standard Operating Procedures for the Company in accordance to customer compliance requirements.
• Reviews quality assurance standards, studies existing policies and procedures, and interviews company personnel and customers to evaluate effectiveness of the quality assurance program.
• Conducts management and training meetings with any/all applicable company personnel to establish, delineate, and review standard operating procedures, organizational policies, and also to coordinate functions and operations between departments.
• Supervises a staff of laboratory technicians and inspectors.
• Cooperates with other top management personnel in formulating and establishing company policies, standard operating procedures, and goals.
• Lead and participate in facility Lean Manufacturing operations through Kaizens, RCAs, Gemba, continuous improvement tools etc.
• Focus on continuous improvement and support the company's Lean Manufacturing Philosophy.
• Develops, implements, revises and audits Standard Operating Procedures for the Company in accordance to governing regulations including FDA, ATF, OSHA, and other various state and local agencies. Reviews technical problems and SOP's of the Company and recommends solutions to problems or changes in procedure(s).
• Provides assistance in the submission of required regulatory documents and reports for the Company in accordance to governing regulatory agencies including FDA, ATF, OSHA, and other state and local agencies.
• Reviews, audits and/or approves all Master Formulas and Production Batch Tickets for their accuracy.
• Reviews technical problems and SOPs of the Company and recommends solutions to problems or changes in producedure(s).
• Oversees the performance and interpretation of plant hygiene studies conducted on a quarterly basis.
• Evaluates suspect and contaminated batches by using approved microbiological methods and procedures. Identifies through such testing, any suspect organisms grown from product or ingredient samples.
• Evaluates contents of reports from the Quality Control department and other Company managers.
• Oversees the writing of stability reports on bulk product tested for specified customers.
• Must be able to perform the essential job functions with or without reasonable accommodation without posing a direct threat to the individual or other.
• Complete customer complaints and non-conformance investigations related to Production and the Quality Control departments and implement CAPAs.
• Provide daily direction setting for the team including daily goals, staffing, and ongoing verification of system health.
• Support customer and third-party quality audits.
• Complete risk based internal audits for departments, develop and implement CAPAs based on audit observations.
• Act as NCL's management representative (MR) with responsibility for and authority over:
• Ensuring that processes needed for the quality management system (QMS) are established, implemented, and maintained.
• Reporting to top management on the performance of the QMS and any need for improvement.
• Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization; and
• Liaison with external parties on matters relating to the QMS.Additional Responsibilities:
• Confers with top management personnel regarding financial decisions and fiscal budgets for Quality Assurance Department and Company.
• Handles all regulatory agency and customer-based compliance inspections and manufacturing facility audits.
• Confers with representatives of raw material and package component vendors to obtain information related to supply quality and vendor quality standards.
• Reviews technical publications, articles, and abstracts to stay abreast of technical developments in the drug, cosmetic and personal care product industries.
• Performs other duties as assigned or needed.Elevation Labs provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Elevation Labs complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.Must be able to perform the essential job function with or without reasonable accommodation without posing a direct threat to the individual or others.Incumbent may be asked to perform other duties as assigned.KNOWLEDGE & SKILLS:Ideal Candidate Qualifications:
• Knowledge of Good Manufacturing Practices (cGMPs) is required.
• Experience and knowledge in Cosmetic, Personal Care, OTC drug, and Medical Device regulations with FDA, Health Canada, and other Foreign Markets.
• Knowledge of ISO standards, specifically ISO22718 and ISO13485.
• Flexibility and ability to handle multiple tasks in a short amount of time.
• Knowledge of personal computers and Microsoft Office applications.
• Ability to perform basic mathematical calculations (addition, subtraction, multiplication, division, percentages, etc.).
• Performs work using good organizational and time management skills.
• Performs work with a high degree of accuracy and attention to detail.
• Communicates by written and/or verbal means the nature of out-of-specification test results.
• Works with minimum supervision.
• Perform essential duties and responsibilities efficiently, accurately and safely.Laboratory equipment including, but not limited to:
• pH meter
• Viscometer
• Refractometer
• FTIR
• Microbiology lab equipment
• Copy machine
• Personal computerEDUCATION/EXPERIENCE:
• College degree (A.S. or B.S.) and 10 years of quality control and/or microbiology lab experience. Bachelor's degree in science and/or engineering is preferred.
• Five years related experience in a production or manufacturing environment (cosmetics, food, bottling, etc).
• Previous experience working in a GMP environment preferred.PHYSICAL/MENTAL DEMANDS:
• Ability to lift 25 lbs.
• Regularly required to stand.
• Frequently required to walk.
• Regularly reach with hands and arms.
• Occasionally required to climb or balance; stoop, kneel, crouch or crawl.
• Occasionally required to lift and/or move up to 10 pounds, and occasionally required to lift and/or move up to 50 pounds.
• Sufficient clarity of speech and hearing abilities by this classification includes those which permit the employee to discern verbal instructions and communicate effectively in person and by telephone.
• Requires composure and ability to prioritize and handle many urgent tasks and requests simultaneously with a high level of competence and accuracy.
• Maintain confidentiality.WORK ENVIRONMENT:
• Production Area is HVAC Controlled.
• Warehouse is not HVAC Controlled.
• Regularly required to work in areas where chemical materials are encountered.
• Manufacturing setting with moving machinery.
• Regularly required to wear appropriate personal protective equipment.
• May involve exposure to shop environment including variable noise levels.
• Must customarily have a high consciousness for personnel and equipment safety.In compliance with Colorado's Equal Pay for Equal Work Act, we are disclosing the compensation range for roles that will be, or could be, performed in Colorado. Compensation for similar positions located outside of Colorado may differ.If performed in Colorado, the base salary for this position generally ranges between $140-160K. This salary range may vary based on relevant factors including but not limited to experience, education, performance, scope of responsibilities, location and other considerations permitted by law.
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Keywords: Elevation Labs, Aurora , Director of Quality, Executive , Denver, Colorado