Quality Analyst I

Teva Pharmaceuticals•Cincinnati, OH

3d•Onsite

About The Position

As a Quality Analyst I, your role will involve examining documentation for manufactured and packaged batches to ensure adherence to cGMP standards prior to their release for additional processing, packaging, or entry into the commercial market.

Requirements

Relevant GMP Quality experience may be considered as a substitute for the degree.
Minimum of one year of experience in a heavily regulated manufacturing environment, preferably in the pharmaceutical sector.
Thorough understanding of current Good Manufacturing Practices (cGMPs) is essential.
Ability to perform basic statistical analyses and comprehend AQL sampling plans.
Proficiency in computer applications, including Veeva, eBR, MS Office, and other relevant software is required.
Ability to read, interpret, and adhere to instructions in English, including SOPs, batch records, and cGMPs, is necessary.
Clear and concise communication skills are important for effectively conveying information, summarizing details, and asking questions.
Experience collaborating with cross-functional teams such as planning, manufacturing, packaging, and distribution is crucial to ensure that priorities are established and activities are organized to achieve objectives.

Nice To Haves

4-year Bachelor’s Degree in a Science-related field is highly preferred

Responsibilities

Evaluate and approve manufacturing and packaging documents, along with laboratory test specification records.
Ensure that all relevant information is gathered, assessed, and approved before any product disposition.
Identifies improvements/new procedures/ compliance gaps based on applicable regulations.
Assign QA statuses (Release/Reject/Quarantine/Impound) to both work-in-process and finished product.
Investigate and resolve all routine issues that arise during work assignments.
Coordinate all necessary paperwork for batch release.

Benefits

Generous annual leave
Reward plans
Flexible working schedules (dependent on role)
Access to tailored health support
Meaningful ways to give back to the community
Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment
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.
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