Associate Quality Control Laboratory Analyst
1 week ago
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.
Job Description:Associate Quality Control Laboratory AnalystThe Associate Quality Control Laboratory Analyst will join our team at the Petersburg, Virginia site, bringing their knowledge and experience in service to patients and pursuit of excellence in quality and compliance. Our Petersburg site serves as our fill finish facility dedicated to the manufacture and supply of essential generic and biosimilar insulin sterile injectable medications.
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 us achieve our mission 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.
Key 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.
- Address OOS, OOT, or atypical results on the day of discovery with the appropriate level of urgency.
- Participate in laboratory investigations.
- 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.
- Participate in new 6S and OPEX initiatives.
- Participate in continuous improvement opportunities.
- Ability to work independently or in a team setting effectively.
- Complete chemical inventory and ordering supplies as required.
- Conduct other duties as required by management.
- Bachelor's degree in a scientific discipline with 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 and willingness to learn and help others.
- Working knowledge of relevant FDA and ICH guidelines and USP requirements preferred.
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Associate Quality Control Laboratory Analyst
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US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica 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.Job Description:Associate Quality Control Laboratory AnalystWe are seeking an experienced Associate...
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Quality Control Laboratory Analyst
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US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica 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.Job Description:Quality Control Laboratory AnalystThe Quality Control Laboratory Analyst will play a...
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US-, Petersburg, VA, USA Civica Rx Full timeAbout Civica RxCivica 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.Job Description:Quality Control Laboratory AnalystThe Quality Control Laboratory Analyst will play a...
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Petersburg, United States Civica Rx Full timeAbout 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...
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