Quality & Laboratory Specialist
Omya · Arizona, United States · 3 wk ago
Quality AssuranceFull-time
Based at the USAZ production facility, the Quality & Laboratory Specialist plays an important role in supporting laboratory operations, product quality, and quality system activities. This position combines hands-on laboratory testing with coordination of key quality and laboratory processes to help ensure products consistently meet specification, customer requirements, and regulatory standards.
Responsibilities
- Laboratory Operations and Testing
- Perform routine laboratory testing of raw materials, in-process materials, and finished products.
- Support production through timely and accurate testing and reporting of results.
- Maintain laboratory records and ensure the integrity and traceability of test data.
- Assist with production batch release activities and related documentation.
- Operate, maintain, and troubleshoot laboratory equipment as required.
- Maintain laboratory organization, cleanliness, and compliance with established procedures.
- Provide back-up support for laboratory activities as needed.
- Laboratory Programs and Coordination
- Coordinate and maintain laboratory testing programs, including:
- Stability Testing
- TMYM and OVI Testing
- ICH Q3D Testing
- External laboratory testing activities
- Coordinate laboratory cleaning schedules.
- Support calibration and preventative maintenance programs for laboratory equipment.
- Coordinate laboratory waste management with approved third-party vendors.
- Maintain retain samples and related testing programs.
- Coordinate and maintain laboratory testing programs, including:
- Quality Systems and Compliance
- Assist with maintaining quality management systems and laboratory documentation.
- Support SOP creation, review, and updates.
- Assist with internal GMP audits and compliance activities.
- Participate in investigations, corrective actions, and continuous improvement projects.
- Support customer complaint investigations and follow-up activities.
- Help ensure compliance with applicable food, pharmaceutical, customer, and quality standards.
- Support audit readiness and regulatory compliance activities.
- Laboratory Inventory and Equipment Management
- Monitor inventory levels of laboratory supplies, chemicals, reagents, and consumables.
- Coordinate ordering and replenishment of laboratory materials.
- Maintain laboratory equipment records and calibration status.
- Support equipment servicing and vendor coordination activities.
- Data Management and Reporting
- Support administration and maintenance of LIMS and laboratory data systems.
- Ensure laboratory data is accurately entered, reviewed, and maintained.
- Assist with quality reporting, KPI tracking, and trend analysis.
- Maintain accurate records in accordance with company standards and regulatory requirements.
- Training and Technical Support
- Support laboratory-related training activities and onboarding of personnel.
- Promote compliance with laboratory procedures and Good Laboratory Practices (GLP).
- Assist in sharing best practices and technical knowledge within the laboratory and quality teams.
- Serve as a resource for laboratory processes, testing methods, and quality requirements.
- Health, Safety, Environment and Quality
- Perform all work in compliance with health and safety, environmental, and quality standards.
- Maintain safe laboratory practices and promote a strong safety culture.
- Support site quality objectives and continuous improvement initiatives.
- Ensure adherence to standards supporting industrial, food, and pharmaceutical production.
Requirements
- Education
- Associate's Degree, Technical Diploma, or Bachelor's Degree in Chemistry, Biology, Laboratory Science, Quality Management, Chemical Technology, or a related field.
- Equivalent combinations of education, training, and experience may be considered.
- Experience
- 3 to 5 years of laboratory, quality control, quality assurance, or related manufacturing experience.
- Experience within food, pharmaceutical, chemical, mineral processing, or similarly regulated industries preferred.
- Experience working with laboratory equipment, quality systems, and technical documentation.
- Experience with LIMS or similar laboratory management systems is considered an asset.
- Knowledge and Skills
- Strong understanding of laboratory operations and analytical testing.
- Familiarity with quality systems, documentation control, and continuous improvement principles.
- Knowledge of GMP, GLP, HACCP, ISO, or similar quality standards is considered an asset.
- Strong organizational and time management skills.
- Excellent attention to detail and data accuracy.
- Strong analytical and problem-solving skills.
- Proficient with Microsoft Office and laboratory information systems.
- Ability to communicate effectively with employees at all levels of the organization.
- Team-oriented with the ability to collaborate across multiple functions.
- Working Conditions
- Combination of laboratory and manufacturing environments.
- Exposure to production areas, industrial equipment, chemicals, dust, and noise.
- Regular movement between laboratory and production areas.
- Occasional lifting and handling of laboratory samples and materials.
- Other Requirements
- Ability to work in a fast-paced manufacturing environment.
- Commitment to quality, safety, and continuous improvement.
- Ability to manage multiple priorities while maintaining a high level of accuracy.
Benefits
- Join a global leader in mineral-based specialty solutions.
- Work in a quality-focused environment serving industrial, food, and pharmaceutical markets.
- Develop technical expertise across laboratory operations, quality systems, and manufacturing processes.
- Contribute directly to product quality, regulatory compliance, and continuous improvement initiatives.
- Be part of a collaborative team committed to safety, quality, and operational excellence.