Teva Quality Control Supervisor 

United States, New Jersey 

645163736

Essential Duties & Responsibilities

• Supervise, & Manage QC Scientists, technicians, and coworkers in executing all Lab assignments on time.
• Schedule and track completion of analytical testing of raw materials, finished products, packaging components to support manufacturing plan to meet MPS. Review the data/ LIMS report and release the raw material, finished products. Perform data audits of standards, reagents, and other analytical instrumentation and to do final Approval & product release through LIMS.
• Maintain and update the training curriculum accurately to reflect needs of training and ensure that analysts are trained for the job they are performing
• Ensure to revise laboratory related SOP/test procedures as per compliance requirement.
• Schedule and complete the request testing from other Departments/facility and provide them requested data on time.
• Perform ERP transactions prior to releasing the raw material/packaging components
• Open laboratory investigations and follow investigation SOP to execute and complete investigations on time.
• Ensure the test method/specifications are aligned to USP compendia/ICH guidance.
• Follows TEVA Safety, Health, and Environmental policies and procedures. Perform other duties as assigned or as business needs require.
• Work with packaging engineering to update packaging engineering specification revision for Packaging components.
• Manage cycle time for RM/FG release to meet site KPI.
• Provide support to update/revise testing procedures, protocols, and summary reports when required.
• Support analytical testing and guidance for alternate vendor qualification for API/Excipients.
• Responsible for incoming inspection, testing and releasing raw material, packaging components, purified water.
  

EDUCATION / EXPERIENCE REQUIREMENTS:

• Bachelor’s/Master’s degree in chemistry or related science
• Minimum of ten (10) years of QC laboratory Supervisor/Manager experience
• Analytical service experience and method validation/transfer is preferred

JOB QUALIFICATIONS (Training, skills):

• Knowledge of HPLC, GC and other spectroscopic methods (UV/Vis spectrophotometer, FTIR, Raman spectroscopy), dissolution, wet analysis and other standalone systems and maintain qualification of instruments
• Strong analytical skill to troubleshoot HPLC/GC instruments and Empower data acquisition system
• Knowledge of USP, cGMP, cGLP and ICH requirements in a pharmaceutical quality control laboratory
• Must be detail oriented, self-driven, and motivated
• Good organization skills and attention to detail
• Strong interpersonal, oral, and written communication skills
• Able to work with QC team and effectively supervise
• Knowledge and experience using Labware LIMS documentation system, Trackwise for change controls, laboratory investigations and CAPA
• Knowledge of ERP system SAP
• Good computer skills including MS Office, protocol/report writing/review
• Knowledge of method validation/ method transfer
• Knowledge on Laboratory safety procedures

Physical Requirements

• May be required to lift/move up to 50 lbs.
• Individual may be required to handle hazardous and non-hazardous materials.
• Individual may be required at times to wear Personal Protection Equipment.
• Not allergic to Penicillin/Cephalosporins, chemicals or bio substances found in laboratory or production facilities.
  

We offer a competitive benefits package, including:

• Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
• Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.75% Defined Contribution to the 401k plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but are not limited to, Employee Assistance Program, Employee Stock Purchase Plan, Tuition Assistance, Flexible Spending Accounts, Health Savings Account, Life Style Spending Account, Volunteer Time Off, Paid Parental Leave, if eligible , Family Building Benefits, Virtual Physical Therapy, Accident, Critical Illness and Hospital Indemnity Insurances, Identity Theft Protection, Legal Plan, Voluntary Life Insurance and Long Term Disability and more.

The total compensation may also include restricted stock units and discretionary awards, depending on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

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