Quality Control Associate
West Chester, United States, Pennsylvania, 19380
We Are Teva
Our Team, Your Impact
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: 2–3 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
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 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. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.
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Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to AskHR@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
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Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.