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Quality Control Laboratory Analyst

2 months ago


Washington, Washington, D.C., United States Civica Rx Full time
About Civica Rx

Civica Rx is a 501(c)(4) social welfare organization dedicated to reducing chronic generic drug shortages and related high prices in the United States. Our mission is to deliver quality medicines that are available and affordable to everyone.

We are a team of experienced healthcare and pharmaceutical industry leaders who are passionate about making a difference in the lives of patients. Our organization has grown rapidly, with over 55 health systems joining our cause and representing over 1,500 hospitals and 30% of all U.S. hospital beds.

We have also supplied essential medicines to the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile. Our commitment to patients is unwavering, and we strive to do what is in their best interest.

Job Description

The Quality Control Laboratory Analyst will play a critical role in ensuring the quality and integrity of our sterile injectable products. This position will be responsible for performing analytical testing, interpreting results, and documenting actions and results using proper documentation practices.

The ideal candidate will have a strong background in a regulated laboratory environment, with experience in analytical testing, method verification, and validation. They will also have excellent communication and teamwork skills, with the ability to work effectively in a fast-paced environment.

Key Responsibilities:

  • Perform analytical testing and interpret results
  • Document actions and results using proper documentation practices
  • Participate in analytical method transfers and perform method verifications/validations
  • Notify management of out-of-specification (OOS) or out-of-trend (OOT) results
  • Lead and/or participate in laboratory investigations
  • Maintain LIMS data and contribute to a safety culture
  • Inform management of continuous improvement opportunities

Requirements:

  • Bachelor's degree in a scientific discipline with a minimum of 5 years' experience in a regulated laboratory environment
  • Proficiency with LIMS software, analytical data acquisition software, and Microsoft Office applications
  • Ability to multi-task and change priorities in a fast-paced environment
  • Self-motivated and willingness to learn and help others
  • Working knowledge of relevant FDA and ICH guidelines and USP requirements

What We Offer:

  • A dynamic and growing organization with a mission-driven culture
  • A competitive salary and benefits package
  • Opportunities for professional growth and development