USA

Chem Lab Manager

locationWindsor - Connecticut (CT), 06095

atSCA Pharma

Estimated salary $73,136 - $99,724 a year

Job Description:

SCA Pharma is growing, and we'd love for you to be a part of it!

Summary:

Quality Control (QC) Chemistry Laboratory Manager is responsible for overseeing the day-to-day commercial operation activities within the Quality Control department including raw material/finished product release and stability studies to meet cGMP regulations and project timelines. This individual leads the team and delivers results through the best quality practices and high efficiency. Responsible for implementing procedures to assure compliance with FDA, ICH , DEA and corporate requirements. Manage department KQIs and drive QC continuous improvement in quality and productivity. This position will report to Director of QC Chemistry Laboratory.

Essential Functions:

  • Maintain detailed pharmaceutical industry guidelines/trends, regulatory requirements, and applicable pharmacopoeia while remaining current in on-the-job training requirements
  • Oversee daily aspects of QC Chemistry laboratory including but not limited to testing of raw materials, finished products, and stability / investigation / protocol sample etc.
  • Collaborate with other Quality departments, Manufacturing, Validation, Engineering and Maintenance to support business needs.
  • Responsible for Out of Specification, Out of Trend, Aberrant, deviation, laboratory event investigations including statistical analysis and risk assessment and supports production investigations in a timely manner.
  • Implement QC laboratory CAPAs and the corresponding effectiveness checks to reduce the laboratory errors and meet cGMP requirements.
  • Manage the resources and capacity to meet the department goals and objectives including various release, stability, investigation and project timelines.
  • Supervise laboratory practices, interprets and executes policies and procedures that typically affect the QC Chemistry laboratory operation.
  • Review and/or approve quality documents, e.g., standard operating procedures, specifications, test methods, OOS/OOT/lab event investigations, CAPA, deviations, and change controls, training records, stability protocols/reports, notebooks, testing results, logbooks etc.
  • Support and respond internal and external audits, including third-party contract laboratories and regulatory agency (e.g., FDA, State Board of Pharmacy and DEA), where required in a timely manner.
  • Analyze monthly laboratory performance and quality data (KQI) and develops and institutes quality and efficiency improvements accordingly.
  • Provide technical and compliance guidance to the QC laboratory with strong analytical techniques and
troubleshooting skills in UPLC/HPLC/AA/UV/IR/KF/Particulate Matter etc.
  • Oversee the department training program to ensure personnel have regulatory and compliance training and skills to perform assigned work
  • Write, review and approve QC SOP?s.
  • Ensure Laboratory analysts working in a safe environment.
  • Mentor analysts and conduct performance review and disciplinary actions
  • Occasionally perform weekend and Holiday duties to meet project timelines or requested by Management.

  • Successful Candidates:

    • Strong leadership skills, driving accountability, compliance and efficiency
    • Must be able to interact with other departments on daily basis and make extensive independent judgments.
    • Demonstrate a high level of knowledge of cGMP, ICH, FDA, USP, DEA regulations or guidelines.
    • Significant quality control experience handing OOS/OOT investigations with statistical analysis and risk assessment.
    • Extensive knowledge of Analytical Chemistry theory (especially chromatographic separations by UPLC/HPLC) and the operation and troubleshooting analytical laboratory equipment.
    • Ability to quickly process sophisticated information and often make critical decisions with limited information.
    • Strong analytical lab and stability program management experience
    • Experience in handling control substances in cGMP environment
    • Strong scientific technical writing including authoring SOPs or technical/investigational reports
    • Strong interpersonal and communications skills; written and oral required.
    • Expert-level understanding of technologies and practices for regulated quality labs preferred.
    • Strong troubleshooting skill for QC methods and equipment issues
    • Ability to organize time for multiple tasks and be details oriented
    • Dependable to manage projects to meet pre-determined timelines
    • Ability to work effectively under high pressure with multiple deadlines
    • Be flexible on working hours and be able to be on call during off time since he/she manages two QC shifts operations including occasional weekend work.

    Work Environment

    • This position operates in a chemistry laboratory environment where Proper Protective Equipment is required to wear.


    Qualifications:

    • B.S or Master in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry).
    • Work Experience – at least 10 Years in an analytical quality control laboratory under cGMP regulations in a pharmaceutical company

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