- Salary
- $75k – $100k/yr
- Location
- Denver, CO
- Type
- Full-time
- Department
- IT
- Seniority
- Manager
- Experience
- 5+ years
- Education
- Bachelor
- Source
- ApplicantPro
Description
Job Summary:
The QA Manager leads Quality Assurance operations supporting manufacturing (batching/compounding), production (filling/packaging), and finished goods for Elevation Labs' cosmetic and personal care products. This role oversees the QA team and Quality Management Systems to ensure that materials, processes, and finished products meet internal, customer, regulatory, and applicable organic certification requirements. The QA Manager partners across functions to resolve quality issues, strengthen compliance, and drive continuous improvement of quality performance and processes.
Essential Functions, Key Objectives, and Responsibilities:
- Lead and develop the QA team, overseeing staffing, training, performance management, scheduling, and accountability.
- Manage and improve Quality Management Systems, including change control, document control, calibration, deviations, and training records. Ensure compliance with FDA and other regulatory requirements, customer specifications, organic standards, cGMPs, GLPs, and safety procedures.
- Oversee quality assurance of raw materials, components, intermediates, and finished products, including batch record reviews and product releases.
- Lead CAPA processes, quality investigations, root cause analysis, and resolution of nonconformances, complaints, and out-of-specification results.
- Lead and support internal, customer, third-party, and regulatory audits, ensuring compliance and timely resolution of findings.
- Oversee the development and maintenance of SOPs, work instructions, manufacturing directives, specifications, and quality documentation.
- Manage Certificates of Analysis, laboratory results, customer-required samples, and quality requirements.
- Oversee environmental monitoring, testing, inspections, fill-weight verification, and Bill of Material accuracy, as applicable.
- Monitor quality trends, nonconformances, and rework data to identify risks and drive process improvements.
- Establish departmental goals and KPIs, monitor performance, and drive continuous improvement initiatives.
- Collaborate with Production, Quality Control, R&D, Warehouse, and Supply Chain to resolve quality issues and support operational objectives.
Required Knowledge, Skills, and Competencies
- Strong knowledge of cGMPs, GLPs, Quality Management Systems, regulatory requirements, and cosmetic/personal care manufacturing standards.
- Experience with quality audits, regulatory certifications, controlled documentation, and CAPA processes.
- Strong leadership, coaching, performance management, and team development skills aligned with Elevation Labs' core values.
- Excellent troubleshooting, root cause analysis, risk assessment, and continuous improvement skills; familiarity with 5-Whys or Six Sigma preferred.
- Strong communication, organization, time management, and cross-functional collaboration skills.
- Proficiency in Microsoft Office and ERP systems, with the ability to maintain accurate documentation and follow safety procedures
Education and Experience:
- Bachelor's degree in science, Engineering, or a related field.
- 5+ years of experience in a QA or QC Supervisor or Manager role in a fast-paced manufacturing or production environment; cosmetic, personal care, or OTC contract manufacturing experience strongly preferred.
- 3+ years of experience managing a team of at least three employees.
- ASQ certification(s) strongly preferred.
Physical & Mental demands
- Frequent standing and walking within a manufacturing facility
- Occasional sitting for documentation and administrative tasks
- Regular use of hands and arms for computer work and handling documents
- Occasional bending or reaching during facility walkthroughs
- Ability to lift and/or move up to 10 pounds occasionally
- Ability to communicate effectively in person and via telephone
- Ability to interpret written documents and visual information
Work Environment
- Work is performed in both office and manufacturing environments
- Exposure to a manufacturing setting with moving machinery and moderate noise levels
- Required use of appropriate personal protective equipment (PPE) when in production areas
- Commitment to maintaining a strong safety mindset and adherence to company safety protocols
Travel:
Occasional.