Teva Senior Quality Analyst 

United States, Pennsylvania, East Bradford Township 

590776915

The Quality Analyst III engages in Non-Clinical and Bioanalytical QA related activities at a local and global level, that are planned and performed to assure quality and compliance with applicable procedures and relevant regulations.

This position is filled by a professional, who under the direction of management and more senior auditors executes the program for Good Laboratory Practice (GLP) Quality Assurance, primarily associated GLP regulations and clinical bioanalytical requirements (GCLP). The professional applies experience and excellent communication skills within a collaborative environment to ensure that GLP/GCLP functions are supported with a commitment to continuous quality improvement.

Essential Duties & Responsibilities

• Independently plan, schedule and conduct site audits.
• Independently conduct study protocol audit, amendments, Pharmacokinetics & Immunigenicity data and report audits, and other audits in support of GLP/GCLP studies.
• Execute process-based and study-based audits in a GLP/GCLP Laboratory, in support of regulated studies, for compliance with the study protocol, regulations, and SOPs.
• Perform risk assessments and facility audits of Contract Research Organizations (CROs); Facilitate vendor approval, according to the established process
• Execute internal facility inspections of lab equipment, personnel, methods, computer systems, facilities and records.
• Issue written QA Audit reports for each audit/inspection.
• Participate in SOP, work instruction, form and template development and review.
• Review and approve non-clinical parts of regulatory submissions (e.g. INDs, IBs).
• Provide and support GLP training programs.
• Support inspection readiness of the GLP site and assist during site regulatory inspections.
• Lead investigations into deviations and discrepancies; Participate in the development and completion of corrective actions and preventive actions (CAPA) and process improvement.
• Complete and lead other projects and duties as required/assigned; Manage multiple interfaces and tasks concurrently.
• Follow Teva Safety, Health and Environmental policies and procedures.

Position Requirements

Education Required:
BA/BS Degree in a relevant field or higher required

Experience Required: 3-5 years of Quality Assurance experience, specifically in the pharmaceutical, biotechnology, or medical device industry; Professional experience in laboratory work specializing in biological experiments, Bioassays, or GLP research facility preferred

Job-specific Competencies

1. Ability to work independently as well as to effectively communicate and collaborate in a team environment; Fluent in English
2. Ability to use common software applications (Word, Excel, Power Point); Experience using other computer software

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, 13 paid Holidays and 3 paid floating holidays.
• Life and Disability Protection: Company paid Life and Disability insurance.
• Additional benefits include, but 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.

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