Senior Quality Control Auditor

Job Opening for Senior Quality Control Auditor, Carmel, NY : Client: Lannett Company This is a 6+ month contract engagement with a potential transition to perm. The Senior Quality Control Auditor reports directly to the Quality Control Manager and is responsible for performing the review of laboratory notebooks and data generated from the testing of routine tests on active pharmaceutical ingredients, excipients, in-process and finished products using wet chemical, physical and instruments. The Senior Quality Control Auditor works independently in addition to acting as a reviewer on test procedures, SOPs, technical documents and other record types as required. Assists with special projects and other tasks as deemed necessary. Responsibilities: Work within a team environment of <25 individuals performing day-to-day laboratory activities. Tasks are guided by management. This role has limited scheduling responsibilities, it does not have management or budget responsibilities Perform accurate and timely review of analytical testing for components, supplies, raw materials, finished and intermediate products, manufacturing equipment cleaning samples for both Operations and Development groups Perform review of laboratory equipment calibration/verification and preventative maintenance. Perform the review of method validation and method transfer testing data for components, supplies, raw materials, finished and intermediate products, manufacturing equipment cleaning samples for both Operations and Development group Review SOPs and other technical documents Assist with development of laboratory work instructions Assist with the performance of laboratory method troubleshooting and OOS/OOT investigations Keep abreast of all compendial changes and regulatory requirements Train and Mentor other auditors Document all laboratory data reviews and legible notebooks records Entry of all necessary information into the appropriate database in a timely manner for trending and capacity modeling purposes Qualifications: Bachelor’s degree in Chemistry and 10+ years of laboratory experience or a master’s degree in Chemistry and 8+ years of experience, preferably within a pharmaceutical or manufacturing environment Knowledge of cGMP and other regulatory requirements Thorough understanding of pharmaceutical development and manufacturing SME of laboratory testing procedures and instruments, especially HPLC & GC SME for Method Development and Validation procedures Knowledge of USP/NF methodology and relevant requirements Ability to wear PPE, gown up for analytical lab testing area Ability to perform general office tasks

Job Opening for Senior Quality Control Auditor, Carmel, NY : Client: Lannett Company This is a 6+ month contract engagement with a potential transition to perm. The Senior Quality Control Auditor reports directly to the Quality Control Manager and is responsible for performing the review of laboratory notebooks and data generated from the testing of routine tests on active pharmaceutical ingredients, excipients, in-process and finished products using wet chemical, physical and instruments. The Senior Quality Control Auditor works independently in addition to acting as a reviewer on test procedures, SOPs, technical documents and other record types as required. Assists with special projects and other tasks as deemed necessary.  Responsibilities:

    Work within a team environment of <25 individuals performing day-to-day laboratory activities. Tasks are guided by management. This role has limited scheduling responsibilities, it does not have management or budget responsibilities
    Perform accurate and timely review of analytical testing for components, supplies, raw materials, finished and intermediate products, manufacturing equipment cleaning samples for both Operations and Development groups
    Perform review of laboratory equipment calibration/verification and preventative maintenance.
    Perform the review of method validation and method transfer testing data for components, supplies, raw materials, finished and intermediate products, manufacturing equipment cleaning samples for both Operations and Development group
    Review SOPs and other technical documents
    Assist with development of laboratory work instructions
    Assist with the performance of laboratory method troubleshooting and OOS/OOT investigations
    Keep abreast of all compendial changes and regulatory requirements
    Train and Mentor other auditors
    Document all laboratory data reviews and legible notebooks records
    Entry of all necessary information into the appropriate database in a timely manner for trending and capacity modeling purposes

Qualifications:

    Bachelor’s degree in Chemistry and 10+ years of laboratory experience or a master’s degree in Chemistry and 8+ years of experience, preferably within a pharmaceutical or manufacturing environment
    Knowledge of cGMP and other regulatory requirements
    Thorough understanding of pharmaceutical development and manufacturing
    SME of laboratory testing procedures and instruments, especially HPLC & GC
    SME for Method Development and Validation procedures
    Knowledge of USP/NF methodology and relevant requirements
    Ability to wear PPE, gown up for analytical lab testing area
    Ability to perform general office tasks