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.
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, 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.
Important notice to Employment Agencies - Please Read Carefully 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.