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Quality Control Data Reviewer

Germer International - Pharmaceutical Recruiting • Pearl River, NY 10965 • Posted 3 days ago via LinkedIn

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In-person • Full-time • Mid Level

Job Highlights

Using AI ⚡ to summarize the original job post

The Quality Control/Quality Assurance Data Reviewer role involves hands-on testing in a Quality Control laboratory operating within a cGMP environment, including a review of laboratory notebooks, electronic data files, and laboratory systems such as Reference Standards and Instrumentation Logbooks. This position requires a Bachelor’s degree in chemistry, 2+ years of experience in the pharmaceutical industry, and proficiency in HPLC, GC, Dissolution, and Empower software.

Responsibilities

  • Review and approve hard copy notebook pages for the Laboratory Analysts in the QC and AR&D laboratory team.
  • Review and sign-off of electronic data files within the Empower data acquisition software system.
  • Conduct a review of the Reference Standard logs for completeness and remove any expired standard materials.
  • Conduct a periodic review of instrument logbooks and work with the team to correct any omissions.
  • Support the laboratory analysts to ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs).
  • Conduct a review of the column inventory logs for completeness and remove any damaged or unusable columns.

Qualifications

Required

  • Bachelor’s degree in chemistry
  • 2+ years of experience in the pharmaceutical industry
  • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software
  • Strong analytical and problem-solving skills
  • Excellent communication and teamwork skills
  • Attention to detail and commitment to maintaining data integrity

About Germer International - Pharmaceutical Recruiting

Germer International is a renowned company specializing in pharmaceutical, biotech, and medical device recruitment, offering permanent placement at all levels nationwide. With over 25 years of experience, they aim to be a trusted partner in helping professionals find the right positions in these industries. Led by Catherine Stier, their team of experts provides personalized service to meet the unique needs of clients and candidates.

Full Job Description

Our pharmaceutical client, is looking for a Data Reviewer to join their team! If you are someone who wants to be apart of a growing and technical environvment and gain further exposure to Quality systems, this might be the role for you!


This position requires experience with hands on testing in a Quality Control laboratory operating within a cGMP environment. This review will also extend to Quality Systems in the laboratory such as Reference Standards, Instrumentation Logbooks, LC/GC Column Inventory, etc.


Key Responsibilities:


  • Review and approve hard copy notebook pages for the Laboratory Analysts in the QC and AR&D laboratory team.
  • Review and sign-off of electronic data files within the Empower data acquisition software system.
  • Conduct a review of the Reference Standard logs for completeness and remove any expired standard materials.
  • Conduct a periodic review of instrument logbooks and work with the team to correct any omissions.
  • Support the laboratory analysts to ensure that all laboratory work complies with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP), following established Standard Operating Procedures (SOPs).
  • Conduct a review of the column inventory logs for completeness and remove any damaged or unusable columns.



Minimum Qualifications:

  • Bachelor’s degree in chemistry
  • 2+ years of experience in the pharmaceutical industry.
  • Hands-on experience with HPLC, GC, Dissolution, and use of Empower software.
  • Strong analytical and problem-solving skills.
  • Excellent communication and teamwork skills.
  • Attention to detail and commitment to maintaining data integrity.