Chemist II, Analytical R&D
Our Chemist II, Analytical R&D, plays a vital role within our organization. Once you complete our training, your responsibilities will include performing and conducting analysis on controlled and non-controlled drug products. This role will also perform testing for development protocols, investigation protocols, stability studies, Raw Materials protocol, or impurity and potency method development. This individual will execute testing per protocol or current test methods and follow all applicable SOPs and cGMP guidelines. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement. Your attention to detail and adherence to precise procedures will guarantee that our medications meet the highest standards of safety, efficacy, and quality, providing patients with the best possible care and outcomes. Turn your passion for precision and your commitment to quality into a meaningful impact on healthcare across the US.
What the Chemist II, Analytical R&D Does Each Day:- Conducts analytical testing of finished sterile products, and raw materials, following all written procedures and cGMP, and providing documentation of analyses to support QC as needed
- Perform analytical testing of new formulation and development samples
- Understand and interpret or validate existing USP methods
- Ability to perform secondary review of raw data, interim results, and final reports
- Participate in method validations and method update activities with oversight from Manager or other Scientists
- Works with the Manger to understand overall expectations and execute them independently based on the prioritization of projects
- Works with the Manager to understand overall expectations and provide data to meet project milestones
- Reads and understands SOPs and follow policy, procedure, and applicable government regulations, such as current Good Manufacturing Practices (cGMP), DEA compliance, quality standards, and safety requirements
- Provide analytical data in a timely manner; This includes understanding of Manager's expectations
- Keeps accurate notebook records and electronic records in accordance with SOPs, cGMP, and current Good Documentation Practices (cGDP) requirements
- Communicates as needed any testing issues to manager or to a cross-functional development project support group
- Recommendations to Manager improvements to analytical test methods or to instrumentation
- Is highly organized with high attention to detail
- Is flexible and able to work in a team environment
- Has knowledge of Microsoft programs such as Word and Excel
- Has good communication skills
- B.S. or M.S. degree in chemistry, biology, or related field
- 2-4 years minimum laboratory experience in the Pharmaceutical Industry
- Understanding of cGMPs and Good Documentation Practice
- Understanding and hands-on experience with various laboratory instrumentation
- Has experience with Waters H-class UPLC and Empower software required
- Has experience with UV-Vis, titration, and other analytical equipment for determination of potency and impurities required
- 18+ years of age
- Able to successfully complete a drug and background check
- Must be currently authorized to work in the United States on a full-time basis; Quva is not able to sponsor applicants for work visas
- Set, full-time, consistent work schedule
- Comprehensive health and wellness benefits including medical, dental and vision
- 401k retirement program with company match
- 17 paid days off plus 8 paid holidays per year
- Occasional weekend and overtime opportunities with advance notice
- National, industry-leading high growth company with future career advancement opportunities
For further information, please review the Know Your Rights notice from the Department of Labor.
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