A Quality Control Analyst, in the biotech and medical device industries, works in laboratories performing biological, microbiological, and chemical tests on products and materials. Responsible for calibrating equipment, inspecting products, processing and testing materials, and reporting results. May work in other production environments to monitor and improve quality and efficiency in production systems and products.
Quality Control Method Development Specialist ProCaps Labs - 3.2 Henderson, NV Job Details Full-time 1 hour ago Benefits Wellness program Health savings account Disability insurance Health insurance Dental insurance Paid time off Vision insurance 401(k) matching Gym membership Life insurance Referral program Pet insurance Qualifications USP standards Pharmaceutical regulatory compliance High-performance liquid chromatographs ICH guidelines Bachelor's degree Gas chromatographs Pharmaceutical analysis Materials analysis (analytical chemistry specialty) Productivity software Test validation method Ultraviolet-visible spectrometers Validation design Full Job Description The Quality Control Method Development Specialist is responsible for providing technical leadership for analytical method development, optimization, validation, verification, and transfer activities in support of
ISO/IEC 17025
accreditation requirements, cGMP compliance, and laboratory quality system objectives. This position serves as the laboratory subject matter expert for analytical methodologies and instrumentation, including HPLC, GC, ICP-MS, HPTLC, UV/Vis, Protein Analyzer, and other laboratory technologies. The Method Development Specialist supports implementation of new analytical technologies, leads technical aspects of laboratory investigations, develops and executes validation protocols, and collaborates with Quality Control Operations, Product Development, Quality Assurance, and other stakeholders to ensure analytical methods are scientifically sound, compliant, and fit for intended use. This role is a key member of the Quality Control Compliance Team and plays a critical role in maintaining accreditation, reducing validation backlogs, improving data quality, and supporting continuous improvement initiatives. Requirements
MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS
Bachelor's degree in chemistry, Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or another natural or physical science. 3+ years of experience in analytical method development, validation, or laboratory quality control. Demonstrated experience with analytical method development and validation. Experience working in a regulated laboratory environment. Strong understanding of analytical chemistry principles and laboratory investigations. Proficiency with Microsoft Office applications. Strong working knowledge and experience in HPLC, GC, ICP-MS, UV/VIS, HPTLC or similar laboratory instrumentation Familiar with
USP, AOAC, ICH, ISO/IEC
17025 and other analytical method development bodies
OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES
Develop, optimize, implement, and troubleshoot analytical methods for raw materials, in-process materials, finished products, stability programs, and new product formulations. Adapt USP, AOAC, customer, regulatory, and published methods for existing laboratory instrumentation and applications. Design and execute method validation, verification, transfer, equivalency, and performance studies. Prepare validation protocols, reports, technical assessments, and supporting documentation while maintaining validation master plans and roadmaps. Establish scientifically justified acceptance criteria and validation parameters. Lead the implementation, qualification, verification, and integration of new analytical instrumentation and technologies. Develop methodologies and procedures for emerging technologies, including HPTLC and Protein Analyzer platforms. Identify and implement opportunities to improve testing efficiency, accuracy, throughput, and automation. Serve as the laboratory subject matter expert for analytical methods, instrumentation, data interpretation, and technical troubleshooting. Provide technical support, training, competency development, mentoring, and problem-solving guidance to laboratory personnel. Lead technical assessments and investigations related to OOS, OOT, atypical results, and laboratory nonconformances. Support root cause analyses, CAPA development, analytical data reviews, trend evaluations, and continuous method improvement. Ensure method development, validation, and laboratory activities comply with ISO/IEC 17025, cGMP, data integrity, and applicable regulatory requirements. Support audits, accreditation assessments, regulatory inspections, internal audits, and maintain audit-ready documentation. Drive quality system improvements by reducing validation backlogs, improving laboratory performance metrics, enhancing method robustness and efficiency, supporting timely investigations, and contributing to continuous audit readiness and compliance.
WORK ENVIRONMENT
Work is performed primarily in a smoke-free laboratory and office environment. Exposure to chemicals, laboratory equipment, and production areas may occur. Appropriate personal protective equipment (PPE) must be worn when required.
PHYSICAL REQUIREMENTS
Frequent sitting, standing, walking, and climbing Able to lift up to 25 lbs. Benefits ProCaps provides : A competitive salary! Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program! Paid Time Off, Eight (8) Company Holidays 401(k) with Company Match - up to 4.5% 100% Company Life Coverage 100% Short Term Disability Coverage Gym Membership Reimbursement Vitamin Allowance + Discounts Company-Funded Health Savings Account ($1,600/year) Cash Reward Employee Referral Program Pet Insurance •Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!
