Quality Control Associate

Quality Control Associate

Location: West Chester, Pennsylvania, United States, 19380 Company: Teva Pharmaceuticals

We're Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it's innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we're dedicated to addressing patients' needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

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.

How You'll Spend Your Day

• 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.

Your Skills and Experience

• Education Minimum: BS/MS in applicable discipline Preferred: Biochemistry, Biology
• Experience Minimum: 1 year in the (Bio)pharmaceutical industry with bioassays/potency assays Preferred: 23 years in the (Bio)pharmaceutical industry with bioassays/potency assays
• Also Good to Have Physical Requirements: Ability to lift 25 pounds. Specialized Knowledge: LIMS, Trackwise, SoftMax Pro

How We'll Take Care of You

• 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.