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.
What You'll Do The QC Analyst II performs analytical chemistry testing and laboratory activities supporting raw materials, in-process samples, finished goods, and stability programs under cGMP conditions, ensuring product quality, regulatory compliance, and timely release of materials. In this role, you develop subject matter expertise in analytical testing methodologies, laboratory instrumentation, and quality control systems within regulated pharmaceutical and medical device environments. How You'll Contribute Perform analytical testing of incoming raw materials according to
USP, EP, ACS
Reagent Index, and approved internal methods. Execute analytical chemistry assays for in-process, release, stability, Engineering, and R D samples using chromatographic, spectroscopic, and wet chemistry techniques. Operate and maintain laboratory instrumentation including HPLC, GC, GC/MS, UV/Vis spectrophotometers, FTIR spectrophotometers, pH meters, osmometers, TOC analyzers, conductivity meters, viscometers, and titration systems. Perform analytical testing using techniques such as Karl Fischer moisture analysis, headspace analysis, auto and manual titrations, viscosity testing, and compendial identification testing. Complete laboratory documentation and data recording activities in accordance with Good Documentation Practices (GDP), cGMP requirements, and internal procedures. Review laboratory notebooks, verify analytical results, and support data integrity and compliance activities. Collaborate with R D and cross-functional teams to support development, transfer, qualification, and validation of analytical test methods for new products and processes. Research, optimize, qualify, and validate analytical methods in accordance with industry best practices and regulatory expectations. Report deviations and nonconformances, participate in laboratory investigations, and support implementation and closure of corrective actions. Maintain training compliance for assigned procedures, laboratory techniques, and safety requirements. Perform routine maintenance and upkeep of general laboratory equipment and instrumentation. Support continuous improvement initiatives and participate in additional projects as assigned. What It Takes This role requires the ability to work on analytical and laboratory assignments of moderate complexity where data analysis and interpretation require evaluation of variable factors and sound scientific judgment. The position operates within established procedures and quality systems while exercising initiative in troubleshooting, prioritization, and execution of laboratory activities. Success in this role requires strong technical laboratory skills, attention to detail, effective organization, and the ability to manage multiple priorities in a regulated manufacturing environment. What You Bring Bachelor's degree in Chemistry, Physical Science, or related scientific discipline; equivalent experience may be considered. 2-5 years of analytical testing experience within FDA-regulated pharmaceutical or medical device industries. Demonstrated knowledge of GMP and ISO regulatory requirements. Hands-on experience with HPLC and GC analyses, including method development and method validation activities. Experience using laboratory instrumentation including UV/Vis spectrophotometers, FTIR spectrophotometers, pH meters, and osmometers. Skilled in wet chemistry techniques including titrations and compendial identification testing. Strong documentation, organizational, and problem-solving skills. Ability to manage multiple priorities and meet established timelines in a fast-paced laboratory environment. Willingness and flexibility to support varying work schedules as needed to complete laboratory activities. Nice to Have Experience with
GC/MS, TOC
analyzers, conductivity meters, and viscometers. Experience supporting analytical method transfers and qualification activities. Familiarity with stability testing programs and analytical trending activities. Experience working in a collaborative, results-driven team environment. Proficiency maintaining spreadsheets and preparing basic graphs or analytical trend reports. Compensation & Benefits The salary range provided is based on the Company's reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life. The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.
