Quality Control Laboratory Analyst
5 days ago
Joseph Health, SSM Health, and Trinity Health) and philanthropies (Gary and Mary West Foundation, Laura and John Arnold Foundation, and Peterson Center on Healthcare) to reduce chronic generic drug shortages and related high prices in the United States. An experienced team of health care and pharmaceutical industry leaders leads the organization.
Department of Veteran's Affairs, the U.Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
The Quality Control Laboratory Analyst will join the Civica, Inc. ("Civica") organization and its newly forming team at the Petersburg, Virginia site by bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. The Petersburg site serves as Civica's new fill finish facility dedicated to the manufacture and supply of essential generic and biosimilar insulin sterile injectable medications. Responsibilities of the position include performing analytical testing on sterile injectable products. Responsibilities also include maintenance of analytical equipment and executing method verification, validations, and transfers.
The role is essential to assure the intended materials are utilized for manufacturing and meet the required standards to ensure the finished product meets the applicable standards of identity, strength, quality, and purity. You will help Civica achieve its mission of delivering quality medicines that are available and affordable to everyone by complying with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDA Guidance documents) and expectations for the development and reliable supply of quality medicines.
Perform analytical testing, interpret results, and document actions and results using proper documentation practices.
Lead and/or participate in laboratory investigations.
Ability to complete HPLC analysis with minimal supervision. Experience with Empower software, and PDA or QDa detection is a plus.
Maintain LIMS data.
Complete chemical inventory and ordering supplies as required.
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, Microsoft Office® applications including Excel, Word, and PowerPoint.
Self-motivated and willingness to learn and help others.
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.
PandoLogic. Keywords: Quality Control / Quality Assurance Analyst, Location:
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