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Quality Analyst

Maxis Clinical Sciences

Quality Analyst

Ridgefield, CT
Full Time
Paid
  • Responsibilities

    Job Description

    Job Description

    We are seeking a highly skilled Raw Material Expert with extensive knowledge and hands-on experience in Raman spectroscopy. The successful candidate will be responsible for the analysis and characterization of raw materials, ensuring their quality and suitability for production processes. This role involves working closely with cross-functional teams to develop and implement testing protocols, troubleshoot material issues, and support continuous improvement initiatives.

    Essential Functions:
    • Conduct detailed analysis of raw materials using Raman spectroscopy and other analytical techniques.
    • Develop and validate testing methods to ensure the a ccuracy and reliability of material characterization.
    • Collaborate with R&D, quality assurance, and production teams to address material-related challenges.
    • Maintain accurate records of all analyses and prepare comprehensive reports.
    • Stay updated with the latest advancements in Raman spectroscopy and material science.

    Requirements
    Education and Experience
    Bachelor's or Master's degree in Chemistry, Material Science, or a related field.
    • Proven experience in using Raman spectroscopy for material analysis.
    • Strong understanding of material properties and their impact on production processes.
    • Excellent problem-solving skills and attention to detail.
    • Ability to work effectively in a team-oriented environment.
    • Training within a regulated Pharmaceutical/biotech/medical device environment.
    • Understanding and application of cGMP's (EP, JP, USP).
    • Detailed knowledge and application with electronic Quality Systems and Data Integrity.

    Technical
    • Strong attention to detail as demonstrated through consistent quality of work.
    • Excellent written and verbal communication skills.
    Computer proficiency in MS Word and Excel, MS Access required.
    Demonstrates process orientation—thinks through required steps and sequencing to ensure quality work output.
    • Ability to anticipate potential problems and take proactive action to avoid/minimize impact. Function as change agent to ensure accurate and timely facilitation of global and department, GMP, etc. changes.

    • Anticipates consequences of actions and how they impact other areas.
    • Ability to utilize project management skills to independently prioritize, plan and schedule workflow.
    • Timely follow up to ensure satisfactory resolution to issues.
    • Knowledge of CGMPs (relevant laws, guidance, directives, and industry practice), and demonstrated ability to apply learnings appropriately in a controlled environment.
    • Ability to interpret and apply GMPs, relevant laws, guidance's, and directives to extremely complex pharmaceutical situations.

    • Ability to work and coordinate activities across multiple functional groups with a sense of professionalism and urgency.
    • Ability to work collaboratively with internal and external team members and customers/contacts.
    • Self-motivated; able to work with minimal supervision. Exercises independent judgment in evaluating compliance.

    Company Description

    Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.

    Our popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.

    Company Description

    Maxis Clinical Sciences provides complete Solution for Clinical and Digital Services. Maxis Clinical Sciences has been recognized in the industry for years, and an integrated research competence center. The company provides 24×7 delivery globally, with teams across the world’s 3 largest continents – North America, Europe and Asia. We operates with a problem-solving approach that believes in promoting genuine relationships & steady communication. It works as true clinical and digital competence center and provides services with 200 plus techno-functional, domain experts, each with 12+ years of average experience.\r\n\r\nOur popular service niches that earned us global accolades are: clinical data management, clinical analytics, patient-centric technology enablement services, statistical analysis and reporting services, data anonymization services, RWD aggregation and curation services etc.