Quality Control Analyst II

About the Role

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Our Finished Product team is looking to add an experienced analyst with a high understanding of instrumentation and a desire to be multifunctional within the team. You will perform critical testing on the release of pharmaceuticals for human consumption and ensure that instrumentation is maintained, qualified, calibrated, and in good working order.

Responsibilities

• Perform routine and non-routine chemical testing of commercial, validation, and stability samples in accordance with written methodology.
• Perform qualitative and quantitative analyses using analytical instrumentation such as HPLC, GC, UV/Vis, KF, and FTIR.
• Utilize electronic laboratory information systems such as LIMS and Empower for acquisition and processing of analytical data.
• Analyze data against approved specifications, notifying management of any OOS and aberrant results.
• Actively participate in root cause problem solving during laboratory investigations; provide input for effective corrective and preventive actions.
• Perform routine maintenance on lab equipment as needed.
• Perform metrology calibrations and preventative maintenance tasks.
• Demonstrate knowledge and understanding of USP, cGMP, and FDA regulations.
• Create and maintain lab record documentation (notebooks and computer-based) according to GMPs.
• Demonstrate the philosophy of Right First Time.
• Maintain a clean and safe work environment and follow safety procedures and policies.
• Provide feedback on systems and processes to promote continuous improvement and champion selected changes.
• Grow in the job, accountable for establishing and accomplishing annual personal development goals.
• Communicate clearly and effectively within a team environment.
• Participate in daily direction-setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives.
• Share information with others—keeping management informed and helping the department meet its goals.
• Actively participate in regular one-on-one meetings with your direct supervisor.
• Communicate externally with the department and vendors.
• Collaborate effectively to achieve team and organizational goals.

Requirements

• Bachelor’s degree required.
• A minimum of 3 years of experience in a pharmaceutical environment or similar regulated environment.
• Basic knowledge and understanding of USP, cGMP, and FDA regulations.
• Experience creating and maintaining lab record documentation (notebooks and computer-based) according to GMPs.
• Experience maintaining a clean and safe work environment and following safety procedures and policies.
• Use of Empower and integrated LIMS systems.
• Experience calibrating HPLC/GC systems.
• Ability to maintain, diagnose, and work on laboratory instrumentation.

Skills

• Prioritize assigned work to maximize time and equipment efficiency.
• Work independently with limited supervision for routine assignments.
• Troubleshoot problems encountered with methods and instruments—routinely solve, choosing among clearly defined alternatives.
• Responsible for the accurate, timely, and compliant execution of assigned projects, analytical testing, and related documentation.

Benefits

• Comprehensive Health Insurance: Medical, dental, vision, and prescription coverage starting on the first day of employment (if the employee enrolls).
• Retirement Savings: 401(k) with employer match up to 6% and an annual 3.75% defined contribution to the 401(k) plan.
• Time Off: Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid holidays, and 3 paid floating holidays.
• Life and Disability Protection: Company-paid life and disability insurance.
• Additional Benefits:
  • Employee Assistance Program
  • Employee Stock Purchase Plan
  • Tuition Assistance
  • Flexible Spending Accounts
  • Health Savings Account
  • Lifestyle 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