Senior Peer Reviewer

Description:

Peer Reviewer III is responsible for reviewing and approving data that is generated by the laboratory to ensure accuracy and compliance with procedures and cGMP requirements. Complete audit tasks withing specified time frame without compromising quality of audit. Continuously improve the documentation system to increase efficiency and GLP compliance. Report all audit findings in audit reports and highlights as well as report any critical deficiencies.

Essential Functions:

• Review laboratory testing records with respect to written procedures/specifications, SOPS, and company policies.
• Review laboratory instrument calibration/qualification records, standard qualification records and records associated with investigations
• Review Raw-material, Excipients, Finished Product for data integrity, compliance with Specifications, Methods and USP monographs as applicable
• Review Analytical Method Validation/Verification data for compliance with Protocols and ICH guidelines
• Review stability data to identify any trends, alert limits and OOS
• Participation in audit of laboratory activities to determine improvement needs for maintenance of cGMP compliance
• Prepare for Pre-Approval Audits for Filed ANDAs

Additional Responsibilities:

• Perform other duties as assigned.

Education:

• Bachelors Degree (BA/BS) - Required

Experience:

• 6 years or more in scientist or group leader in pharmaceutical lab

The base salary for this position ranges from $100,000 to $115,000 per year.   Amneal ranges reflect the Company’s good faith estimate of base salary that 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, 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 helps you enjoy your career alongside life’s many other commitments and opportunities.