Quality Control Analyst II

Summary

Teva Pharmaceuticals is an innovative biopharmaceutical company with a generics business focused on delivering high-quality medicines. The Quality Control Analyst II performs chemical testing and analytical data analysis for pharmaceutical samples, while maintaining, calibrating, and troubleshooting laboratory instrumentation and supporting compliant laboratory operations.

Responsibilities

• Perform routine and non-routine chemical testing of commercial, validation and stability samples in accordance to 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, as needed
• Knowledge and understandingof 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 well within a team environment
• Participate in daily direction setting huddles to provide feedback and ensure alignment on daily/weekly/monthly objectives
• Shares information with others – keeping management informed and helping department to meet the goals
• Actively participate in regular one-on-one meetings with direct supervisor
• Communicate external to the department and vendors
• Collaborate effectively to achieve team and organizational goals
• Prioritize assigned work to maximize time and equipment efficiency
• Work independentlywith 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

Skills

• Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered
• * Bachelors 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
• * Create and maintain lab record documentation (notebooks and computer based) according to GMPs
• * Maintain a clean and safe work environment and follow safety procedures and policies
• * Use of Empower and intergrated LMS systems
• * Experience calibrating HPLCS/GC Systems
• * Ability to maintain, diagnose and work on laboratory instrumentation
• * Prioritize assigned work to maximize time and equipment efficiency
• * Work independentlywith 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

Qualifications

Must Haves

• Any equivalent combination of education, training, and/or experience that fulfills the requirements of the position will be considered
• * Bachelors 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
• * Create and maintain lab record documentation (notebooks and computer based) according to GMPs
• * Maintain a clean and safe work environment and follow safety procedures and policies
• * Use of Empower and intergrated LMS systems
• * Experience calibrating HPLCS/GC Systems
• * Ability to maintain, diagnose and work on laboratory instrumentation

Nice to Haves

• * Prioritize assigned work to maximize time and equipment efficiency
• * Work independentlywith 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

• Generous annual leave
• Reward plans
• Flexible working schedules (dependent on role)
• Access to tailored health support
• Meaningful ways to give back to the community
• Learning programs
• Short-term projects
• Opportunities for internal growth
• Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls
• 401(k) with employer match, up to 6%
• An annual 3.75% Defined Contribution to the 401k plan
• Paid Time Off including vacation, sick/safe time, caretaker time, 13 paid Holidays and 3 paid floating holidays
• Company paid Life and Disability insurance
• 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
• Long Term Disability insurance