QA Auditing Reviewer

Regulatory Toolkit; Piscataway Township (NJ); On-site; USD 30,000 - 44,000; Full time

Benefits offered by this job

Short-term incentive

Long-term incentive (RSUs)

Comprehensive benefits

401(k) matching

Job summary

Amneal is seeking a QA Auditing Reviewer to thoroughly audit production records, determine batch disposition, and execute decisions in systems like JDE. You will ensure proper storage of held/rejected batches and log data into QA databases. May fill in for in-process QA inspectors as needed.

Requires high school or GED; a Bachelor's in a related field is preferred, with 2+ years in pharmaceutical QA/QC/QM. GMP and 21 CFR knowledge is essential. Benefits and incentive opportunities are offered.

Qualifications

• 2+ years in Pharmaceutical QA, QC or QM.
• GMP standards knowledge and 21 CFR Parts 210, 211, 820.

Responsibilities

• Thoroughly audit production records and determine batch disposition (Release, Hold, Reject).
• Physically perform batch disposition for each lot and enter in JDE.
• Ensure batches on Hold/Reject are stored in designated restricted areas.
• Log RFT data per QA processes and load batch data into APR database if required.
• Communicate clearly, orally and in writing; operate calculators and PCs.
• Perform timely reviews of QA In-Process Data.

Education

High School or GED

Bachelor's Degree in Related Field

Job description

Description:

This QA Auditing Reviewer role is responsible for thoroughly auditing production records, determining batch disposition (Release, Hold, Reject), and executing those decisions in systems like JDE while ensuring held or rejected batches are properly controlled and stored. It also logs and loads batch data into required databases, regularly audits QA in-process data, and may fill in for in-process QA inspectors when needed.

Essential Functions:

• Thoroughly audit all production records (work order #1 and #2 for commercial and exhibit batches) and determine batch disposition (Release, Hold, Reject). Physically perform batch disposition for each lot of product produced, including making the correct entries in JDE.
• Responsible for making sure Batches placed on Hold or Reject status are appropriately stored in their designated limited access areas.
• Log RFT data in accordance with established QA Processes
• Load batch data into the APR database (if required)
• Communicating clearly and concisely, both orally and in writing.
• Operating scientific calculators and personal computers
• Performs timely reviews of QA In-Process Data

Additional Responsibilities:

• Must be able to fill in for In-process QA inspectors when circumstances dictate

Education:

• High School or GED - Required
• Bachelors Degree in Related Field - Preferred

Experience:

• 2 years or more in Pharmaceutical QA, QC or QM

Specialized Knowledge:

• Excellent knowledge of manufacturing processes from Raw Material Receipt through finished goods packaging
• Comprehensive understanding of GMP standards, including 21 CFR Parts 210, 211, 820, and relevant ICH guidance.

The hourly rate for this position ranges from $22.00-$32.00 per hour. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.