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QC Supervisor

QC Supervisor

ActalentHauppauge, NY, US
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QC Supervisor

The QC Supervisor is responsible for ensuring compliance and accuracy of protocols and reports related to method validation, verification, and other analytical reports. This role involves monitoring adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations, reviewing Standard Operating Procedures (SOPs), and collaborating with Regulatory Affairs and Analytical Laboratory teams to compile documentation for Abbreviated New Drug Applications (ANDAs).

Responsibilities

  • Ensure compliance and accuracy of protocols and reports related to method validation, verification, and other analytical reports.
  • Monitor adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations.
  • Review and verify Standard Operating Procedures (SOPs) and analytical test methods for regulatory alignment.
  • Validate documentation associated with process characterization and validation activities.
  • Collaborate with Regulatory Affairs and Analytical Laboratory teams to compile documentation for ANDAs.
  • Manage incoming documentation with proper tracking, recording, secure storage, and archival processes.
  • Review and approve laboratory raw data, including audit trails, to ensure data integrity.
  • Identify system gaps during routine monitoring and report findings for corrective action.
  • Participate in laboratory investigations and incident reviews, ensuring compliance measures are implemented.
  • Assess compliance of analytical documentation related to raw materials and finished products.
  • Conduct random internal audits within the analytical laboratory to verify compliance.
  • Evaluate and implement updates from Pharmacopoeia revisions.
  • Support departmental and cross-functional initiatives and projects as assigned.

Essential Skills

  • Bachelor's degree in Chemistry, Pharmaceutical Sciences, or a related discipline; a Master's degree is preferred.
  • Minimum of 8 years of relevant experience in pharmaceutical manufacturing within the Quality function.
  • At least 5 years of hands-on experience in Quality Assurance / Control within a cGMP-compliant environment.
  • Proficient in Microsoft Office and quality-related software applications.
  • Extensive experience in analytical laboratory operations, including APIs, drug products, and compliance with GLP, GMP, GDP, USP monographs, and FDA / ICH guidelines.

    • Additional Skills & Qualifications

  • Skilled in operating, qualifying, and calibrating laboratory instruments such as HPLC, UV-Vis spectrophotometers, and GC.
  • Deep understanding of regulatory requirements including USP monographs, FDA, and ICH guidance.
  • Capable of influencing decision-making and driving progress toward business objectives.
  • Proficient in troubleshooting, conducting investigations, and performing root cause analysis.
  • Experienced in supporting and participating in local and federal compliance audits.
  • Familiarity with inhalation products (e.g., Dry Powder Inhalers) is a plus.
  • Excellent verbal, written, and interpersonal communication skills.
  • Skilled in technical writing and documentation, with the ability to apply scientific principles effectively.

    • Work Environment

    This role operates in a cGMP laboratory or manufacturing environment, requiring personal protective equipment such as uniforms, lab coats, safety glasses, and more. The work schedule is generally from 8 : 30 AM to 5 : 00 PM, though flexibility is required for different shifts, including weekends, based on business needs. Interaction with solvents, powders, or other materials is common in this pharmaceutical setting.

    Job Type & Location

    This is a Permanent position based out of Hauppauge, New York.

    Pay and Benefits

    The pay range for this position is $80,000.00 - $100,000.00 / yr. Benefits start day 1 and they are eligible for 2 weeks vacation, 56 hours sick and wellness add 2 days mental health days.

    Workplace Type

    This is a fully onsite position in Hauppauge, NY.

    Application Deadline

    This position is anticipated to close on Oct 10, 2025.

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    Qc Supervisor • Hauppauge, NY, US