Quality Control Laboratory Analyst
4 weeks ago
Civica Rx is a 501(c)(4) social welfare organization established in 2018 by health systems and philanthropies to reduce 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 have expanded our mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. Our sister organization, CivicaScript, partners with Blue Cross Blue Shield entities and others to reduce select high-cost generic drugs where market forces are not working to control drug costs.
Our team is dedicated to pursuing excellence in quality and compliance, and we are seeking a Quality Control Laboratory Analyst to join our team at our Petersburg, Virginia site. This role is essential to ensuring the quality and purity of our sterile injectable medications.
Job Description:
The Quality Control Laboratory Analyst will be responsible for performing analytical testing on sterile injectable products, maintaining analytical equipment, and executing method verification, validations, and transfers. This role requires a strong understanding of regulatory standards, including Current Good Manufacturing Practices and FDA Guidance documents.
The ideal candidate will have a Bachelor's degree in a scientific discipline and a minimum of 5 years' experience working in a regulated laboratory environment. Proficiency with LIMS software, analytical data acquisition software, and Microsoft Office applications is required. The ability to multi-task and change priorities in a fast-paced environment is essential.
Responsibilities:
* Perform analytical testing, interpret results, and document actions and results using proper documentation practices.
* Participate in analytical method transfers and perform method verifications/validations.
* Notify management of OOS, OOT, or atypical results on the day of discovery with the appropriate level of urgency.
* Lead and/or participate in laboratory investigations.
* Maintain LIMS data.
* Contribute to and promote a safety culture by adhering to established safety procedures, engineering controls, and appropriate PPE.
* Maintain a clean and organized work environment in accordance with 6S lean principles.
* Inform management of continuous improvement and opportunities.
* Lead and/or participate in 6S and OPEX initiatives.
* Ability to work independently or in a team setting effectively.
* Complete chemical inventory and ordering supplies as required.
Requirements:
* Bachelor's degree in a scientific discipline with a minimum of 5 years' experience working in a regulated laboratory environment.
* Proficiency with LIMS software, analytical data acquisition software, and Microsoft Office applications including Excel, Word, and PowerPoint.
* 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 preferred.
Experience with the following:
* Wet chemistry testing by USP methods, pH, conductivity, atomic absorption, and loss on drying.
* Proficient in HPLC analysis.
* Prepare and/or review technical documents such as protocols, reports, SOPs, and testing procedures.
* Experience with GMP and working knowledge of data integrity.
* Familiarity with analytical method transfers, method verifications, and validations.
Why Join Us:
Civica Rx is an Equal Opportunity Employer and a drug-free workplace. We comply with ADA regulations as applicable. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.
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