Quality Control Analyst II

Anika Therapeutics Inc
  • Westborough, MA
    30+ days ago

    Job Description

    Job Description\n \nWhat You'll Do\n \nThe 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.\n \nHow You'll Contribute\n\n Perform analytical testing of incoming raw materials according to USP, EP, ACS Reagent Index, and approved internal methods.\n Execute analytical chemistry assays for in-process, release, stability, Engineering, and R&D samples using chromatographic, spectroscopic, and wet chemistry techniques.\n 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.\n Perform analytical testing using techniques such as Karl Fischer moisture analysis, headspace analysis, auto and manual titrations, viscosity testing, and compendial identification testing.\n Complete laboratory documentation and data recording activities in accordance with Good Documentation Practices (GDP), cGMP requirements, and internal procedures.\n Review laboratory notebooks, verify analytical results, and support data integrity and compliance activities.\n Collaborate with R&D and cross-functional teams to support development, transfer, qualification, and validation of analytical test methods for new products and processes.\n Research, optimize, qualify, and validate analytical methods in accordance with industry best practices and regulatory expectations.\n Report deviations and nonconformances, participate in laboratory investigations, and support implementation and closure of corrective actions.\n Maintain training compliance for assigned procedures, laboratory techniques, and safety requirements.\n Perform routine maintenance and upkeep of general laboratory equipment and instrumentation.\n Support continuous improvement initiatives and participate in additional projects as assigned.\n \nWhat It Takes\n \nThis 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.\n \nWhat You Bring\n\n Bachelor's degree in Chemistry, Physical Science, or related scientific discipline; equivalent experience may be considered.\n 2\u20135 years of analytical testing experience within FDA-regulated pharmaceutical or medical device industries.\n Demonstrated knowledge of GMP and ISO regulatory requirements.\n Hands-on experience with HPLC and GC analyses, including method development and method validation activities.\n Experience using laboratory instrumentation including UV/Vis spectrophotometers, FTIR spectrophotometers, pH meters, and osmometers.\n Skilled in wet chemistry techniques including titrations and compendial identification testing.\n Strong documentation, organizational, and problem-solving skills.\n Ability to manage multiple priorities and meet established timelines in a fast-paced laboratory environment.\n Willingness and flexibility to support varying work schedules as needed to complete laboratory activities.\n \nNice to Have\n\n Experience with GC/MS, TOC analyzers, conductivity meters, and viscometers.\n Experience supporting analytical method transfers and qualification activities.\n Familiarity with stability testing programs and analytical trending activities.\n Experience working in a collaborative, results-driven team environment.\n Proficiency maintaining spreadsheets and preparing basic graphs or analytical trend reports.\n \nThe 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. \n \nThe 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.\n \nPowered by\n \nPosition Details\n \nNow Hiring\n \nEmployment TypeFull-Time\n \nSalary Range$82,000 \u2013 $92,000\n \nApply Now\n \nShare This Career\n\n \n \n \n \n \nReady to Apply?\n \nClick the button below to submit your application for this position.\n \nApply Now\n \nOther Open Positions\n \nCareer\n \nShift Lead Aseptic Manufacturing\n \nFull-Time\u2022Bedford, MA\n \nWhat You'll Do The Shift Lead Aseptic Manufacturing leads day-to-day aseptic manufacturing floor operations for sterile drug and medical device products produced within ISO 5\u2026\n \nView Position\n \nCareer\n \nSenior Warehouse Specialist\n \nFull-Time\u2022Bedford, MA\n \nWhat You'll Do The Senior Warehouse Specialist plays a crucial lead role in managing complex warehouse operations, including domestic and international shipments, inventory control, and\u2026\n \nView Position\n \nCareer\n \nQuality Control Microbiologist\n \nFull-Time\u2022Bedford, MA\n \nWhat You'll Do The QC Microbiologist performs microbiological testing and validation activities supporting commercial manufacturing operations under GMP conditions, ensuring compliance with regulatory requirements, product\u2026\n \nView Position\n \nProducts Navigation" data-detect-dark-bg="true">Products\n\n Regenerative Solutions\n OA Pain Management\n Our Technology\n \nResources Navigation" data-detect-dark-bg="true">Resources\n\n Literature & Videos\n News & Blog\n Just For Patients\n Events\n Certifications\n Form 1095-C\n Instructions for Use\n Find a Doctor\n \nCompany Navigation" data-detect-dark-bg="true">Company\n\n About Anika\n Meet Our Team\n Our Story\n Join Us\n \nConnect Navigation" data-detect-dark-bg="true">Connect\n\n Investor Relations\n Contact Us\n Find a Rep\n \nFollow Us\n\n LinkedIn\n Instagram\n Facebook\n X\n* YouTube\n \n3 Media Web Solutions, Inc\n \n2026 Anika Therapeutics, Inc. 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    Numbers & Facts

    LocationWestborough, MA

    Skills

    • Analysis Skillsunmatched
    • Analytical Chemistryunmatched
    • Analytical Method Validationunmatched
    • Asepsisunmatched
    • Assaysunmatched
    • Best Practicesunmatched
    • Biotech and Pharmaceuticalunmatched
    • Blogunmatched
    • Chemistryunmatched
    • Chromatographyunmatched
    • Compensation and Benefitsunmatched
    • Continuous Improvementunmatched
    • Control Systemsunmatched
    • Corrective Actionunmatched
    • Cross-Functionalunmatched
    • Current Good Manufacturing Practice (cGMP)unmatched
    • Data Analysisunmatched
    • Data Qualityunmatched
    • Detail Orientedunmatched
    • Documentationunmatched
    • Establish Prioritiesunmatched
    • FDA (Food and Drug Administration)unmatched
    • Facebookunmatched
    • Fourier-Transform Infrared Spectroscopy (FTIR)unmatched
    • GMP (Good Manufacturing Practices)unmatched
    • Gas Chromatography-Mass Spectrometry (GC-MS)unmatched
    • High Performance Liquid Chromatography (HPLC)unmatched
    • ISO (International Organization for Standardization)unmatched
    • Identify Issuesunmatched
    • Instrumentationunmatched
    • Inventory Managementunmatched
    • Investor Relationsunmatched
    • Laboratoryunmatched
    • Laboratory Equipmentunmatched
    • Laboratory Notebookunmatched
    • Laboratory Techniquesunmatched
    • Legalunmatched
    • LinkedInunmatched
    • Maintain Complianceunmatched
    • Manufacturingunmatched
    • Manufacturing Operationsunmatched
    • Materials Testingunmatched
    • Medical Equipmentunmatched
    • Medical Productsunmatched
    • Microbiologyunmatched
    • Multitaskingunmatched
    • Navigation Solution (NAVSOL)unmatched
    • Operational Supportunmatched
    • Operations Managementunmatched
    • Organizational Skillsunmatched
    • Pain Managementunmatched
    • Physical Chemistryunmatched
    • Physical Scienceunmatched
    • Problem Solving Skillsunmatched
    • Procedure Developmentunmatched
    • Quality Assurance Methodologyunmatched
    • Quality Controlunmatched
    • Regulationsunmatched
    • Regulatory Complianceunmatched
    • Regulatory Requirementsunmatched
    • Research & Development (R&D)unmatched
    • Safety Trainingunmatched
    • Sample/Specimen Processingunmatched
    • Spreadsheetsunmatched
    • Team Playerunmatched
    • Test Labunmatched
    • Test Programunmatched
    • Testingunmatched
    • Time Managementunmatched
    • Titrationunmatched
    • Trend Analysisunmatched
    • UV/VIS (Ultraviolet-Visible Spectroscopy)unmatched
    • Validation Testingunmatched
    • Videojournalismunmatched
    • Warehousingunmatched
    • YouTubeunmatched

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