Quality Control Associate

Teva Pharmaceuticals • West Chester, IA

5d

About The Position

The Bioassays and Potency Analysis group strives to deliver creative medicines to patients through performance of bioassay, potency and impurities testing activities within a GxP-compliant QC laboratory to support pre-clinical studies and clinical development for biological products manufactured in a GMP production facility. The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements as knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA, etc) are integral responsibilities of this position.

Requirements

• BS/MS in applicable discipline
• 1 year in the (Bio)pharmaceutical industry with bioassays/potency assays

Nice To Haves

• Biochemistry, Biology
• 2–3 years in the (Bio)pharmaceutical industry with bioassays/potency assays
• LIMS, Trackwise, SoftMax Pro

Responsibilities

• Release and stability testing such as cell-based bioassays, ID ELISA, potency ELISA, impurities ELISA (e.g. executing testing, results analysis, peer review of data, etc.)
• Method qualification, validation and transfer.
• Laboratory investigations (e.g. deviations, Out of Specification, Out of Trend results)
• Management of standard operating procedures, work instructions, protocols, reports, and standard practices.
• Actively contribute to the maintenance of a compliant, clean, safe working environment (e.g. records, instruments, equipment, materials, reagents, quality systems etc.) in the laboratories by maintaining compliance with applicable ICH, GMP and safety regulations.
• Participate in internal and external audits, inspections, regulatory assessments, and filings.

Benefits

• 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 holiday.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level