Senior Quality Assurance Auditor

Focus Laboratories • Cherry Hill Township, NJ

3d • Remote

About The Position

Join TPM Laboratories as a Full-Time Senior Quality Assurance Auditor and become part of an innovative team committed to advancing research quality. This fully remote position allows you to work from anywhere while contributing to impactful projects that prioritize customer-centric solutions. With a competitive pay you'll be compensated well for your expertise as you uphold industry standards. As a leader in the research industry based in Cherry Hill, NJ, TPM Laboratories fosters a professional culture that values integrity and forward-thinking approaches.
Apply today to make a difference!
Hello, we're TPM Laboratories
TPM Laboratories, Inc. is an independent contract testing laboratory providing personalized analytical services to the pharmaceutical and chemical industries. TPM Labs specializes in Analytical Research and Development Testing Services, Quality Control Testing and Stability Storage & Testing Services. Our goal is to provide high quality, cost effective and timely service, personalized to meet your needs.
What would you do as a Senior Quality Assurance Auditor
As a Senior Quality Assurance Auditor at TPM Laboratories, you will play a crucial role in maintaining the highest quality standards in research. You will independently conduct quality assurance reviews of analytical test protocols, method validation protocols, and laboratory work to ensure compliance with established procedures. Your responsibilities will include performing QA functions such as checking lab notebooks, reviewing and updating SOPs to align with cGMP requirements, and auditing laboratory and calibration records. You will also analyze trends in laboratory deviations and investigations, tracking them to resolution. Collaborating closely with the QA Manager, you will help coordinate laboratory activities related to quality assurance and contribute to the development of compliance policy guidelines in accordance with FDA and relevant regulations.
Additionally, you will audit training programs for both new hires and experienced staff, ensuring a robust understanding of quality assurance protocols within the team.
Are you a good fit for this Senior Quality Assurance Auditor job?
To excel as a Senior Quality Assurance Auditor at TPM Laboratories, candidates must possess a solid foundation in chemistry or a related discipline, with a Bachelor's degree required and an MS or Ph.D. being highly desirable. With six to eight years of experience in a pharmaceutical laboratory, you will demonstrate a thorough understanding of analytical method validation procedures and laboratory instrumentation. Strong familiarity with cGMP, FDA, ICH, and USP/compendia regulations is essential to ensure compliance in all quality assurance activities.
Excellent organizational and communication skills are necessary for effectively collaborating with team members and conveying audit findings. Additionally, the ability to assess laboratory performance in relation to compliance and quality will be crucial for maintaining TPM Laboratories' commitment to excellence in research. Your expertise will help uphold the integrity and safety of our laboratory operations.

Requirements

• BS in Chemistry or Related Discipline. MS or Ph.D. Degree desirable.
• Six to Eight years experience in a pharmaceutical laboratory.
• Thorough knowledge of analytical method validation procedures.
• Thorough knowledge of laboratory instrumentation and procedures.
• Excellent knowledge of cGMP
• FDA
• ICH and USP/compendia! regulations as they relate to the pharmaceutical laboratory.
• Good organizational and communication skills.
• Ability to assess performance of laboratory with respect to compliance and quality.

Responsibilities

• Independently conduct quality assurance reviews of analytical test protocols, method validation protocols, and laboratory work to ensure compliance with established procedures.
• Perform QA functions such as checking lab notebooks, reviewing and updating SOPs to align with cGMP requirements, and auditing laboratory and calibration records.
• Analyze trends in laboratory deviations and investigations, tracking them to resolution.
• Collaborate closely with the QA Manager to coordinate laboratory activities related to quality assurance and contribute to the development of compliance policy guidelines in accordance with FDA and relevant regulations.
• Audit training programs for both new hires and experienced staff, ensuring a robust understanding of quality assurance protocols within the team.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level