The individual will be required to perform either validation studies for analytical methods, conduct stability analyses on drug product, or test of Raw Materials. This individual will execute testing per current test methods and follow all applicable SOPs and cGMP guidelines.
- This individual will conduct analytical testing of finished sterile products, and raw materials, following all written procedures and cGMP, and providing documentation of analyses.
- This individual will report any issues to the Supervisor upon discovery.
- This individual will work with the Supervisor to understand overall expectations and execute them independently based on the prioritization of projects.
- This individual will work with the Supervisor or Manager to understand overall expectations and provide data to meet project milestones.
Responsibilities may include:
- 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 Supervisor or Manager’s expectations.
- Provide input to R&D SOPs to enhance the efficiency of the laboratory.
- Keep accurate notebook records in accordance with SOPs, cGMP and current Good Documentation Practices (cGDP) requirements
- Communicate as needed any testing issues to either a Supervisor or Manager or to a cross-functional group such as Metrology
- Recommend to Supervisor or Manager improvements to analytical test methods or to instrumentation.
- This individual will draft testing protocols and reports for investigations
- Legally authorized to work in the job posting country
- B.S. or M.S. degree in chemistry, biology or related field with 0- 2 years minimum laboratory experience in the Pharmaceutical Industry
- Understanding of cGMPs and Good Documentation Practice
- Understanding of various laboratory instrumentation
To be considered:
In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.
Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.
It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors