QC Laboratory Associate
1 month ago
About Civica:
Over the past two decades, shortages of generic, injectable medications critical to the lifesaving work of hospitals in the United States have become commonplace and have reached an all time high. Over 300 essential medications are reported to be in shortage, according to industry and FDA reports. "Race to the bottom" pricing of mostly sterile injectable medications, manufacturing challenges and predatory pricing are both the causes and results.
Who suffers most? Patients.
Civica is a 501(c)(4) social welfare organization established in 2018 by health systems (CommonSpirit Health, HCA Healthcare, Intermountain Healthcare, Mayo Clinic, Providence St. 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.
Today, more than 55 health systems have joined Civica. They represent over 1,500 hospitals and over 30 percent of all U.S. hospital beds. Civica has also supplied the U.S. Department of Veteran's Affairs, the U.S. Department of Defense, and the U.S. Strategic National Stockpile of essential medicines. Since established, the #1 Policy for the Civica team has been "Do What Is in the Best Interest of Patients."
Civica has expanded its mission beyond the hospital setting to include lowering the cost of medications at the pharmacy counter. It has launched a sister organization, CivicaScript, to enter the retail pharmacy market partnering with Blue Cross Blue Shield entities and others with the goal of reducing select high cost generic drugs where market forces are not working to control drug costs.
More recently, Civica announced plans to develop, manufacture and deliver affordable biosimilar insulin, The consistent availability of affordable insulin will benefit people who ration their care or who have been forced to choose between this life-sustaining medicine and living expenses. Those who are uninsured or underinsured often pay the most out of pocket for their medications.
Long- and short-acting insulins will be produced and available in both vials and pre-filled pens - at no more than $30 per vial and no more than $55 for a pack of five pens.
Learn more about Civica's plans and progress at www.civicarx.org
Job Description:
The Associate Quality Control Laboratory Analyst will bring their knowledge and experience in service to patients and pursue excellence in quality and compliance. In this role, you will support the manufacture and supply of essential generic and biosimilar insulin sterile injectable medications. The responsibilities of the position include testing biological drug substances and sterile injectable products. Responsibilities also include maintenance of equipment.
The role is essential to ensure the intended materials utilized for manufacturing are tested to ensure the finished product meets the applicable standards of identity, strength, quality, and purity. You will helpCivica achieves its mission of delivering quality medicines that are available and affordable to everyoneby complying with applicable regulatory standards (e.g., Current Good Manufacturing Practices, and FDAGuidance documents) and expectations for the development and reliable supply of quality medicines.
Essential Duties and Responsibilities:
- Perform routine testing, analyze information, interpret results, and document actions and
- results using proper documentation practices.
- Participate in analytical method transfers and method verifications/validations.
- Participate in laboratory investigations.
- Participate in equipment maintenance.
- Maintain a clean and organized work environment in accordance with 6S lean principles.
- Use existing procedures and instructions to solve routine problems.
- Apply technical and functional knowledge to deliver high-quality work.
- Ability to work independently when instruction is received or in a team setting.
- Achieves goals assigned by the manager.
- Inform management of continuous improvement and opportunities.
- Complete chemical inventory and order supplies as required.
- Contribute to and promote a safety culture by adhering to established safety procedures.
- Engineering controls and appropriate PPE.
- Conduct other duties as required by management.
Basic Qualifications and Capabilities:
- Bachelor's degree in a scientific discipline with a minimum of 2+ years' experience working in a regulated laboratory environment.
- Proficiency with Microsoft Office® applications, including Excel, Word, and PowerPoint.
- Ability to multi-task and change priorities in a fast-paced environment.
- Self-motivated, uses time effectively and efficiently and is willing to learn and help others.
- Follows and meets schedules and timelines.
- Working knowledge of relevant FDA and ICH guidelines and USP requirements preferred.
Preferred Qualifications
- Experience with Empower software.
- HPLC analytical experience.
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