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13 Aug 2023
Full-Time Specialist, QC Analytical
Job Description
Responsibilities:
To perform laboratory method validation, qualification and transfer activities. Perform qualification of compendia methods related to raw materials. Perform routine analysis of raw materials, packaging components, in-process materials, drug substance, finished goods and stability samples by appropriate Analytical or Wet Chemistry. Sample incoming materials for packaging and production. Work independently and assist Seniors when necessary.
- Perform method qualification and participate in analytical assay transfer to ensure successful start-up of laboratory.
- Performs compendia method qualifications.
- Executes analytical and wet chemistry methods using HPLC, FTIR, GC, UV-Vis, and other instruments.
- Execute stability program including pulling, testing and report generation. Perform routine water testing.
- Monitor analytical instruments for preventative maintenance and calibration and ensuring conformance to specifications.
- Ensure that IQ/OQ/PQ of new purchased instruments are performed by the vendor in timely manner.
- Troubleshoot instruments in the lab when necessary. Perform a thorough investigation for any lab event/OOS/OOT/OOE results.
- Perform routine QC responsibilities such as sampling, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.
- Generate/Revise general (non-complex) procedures, protocols, and technical reports as needed.
- Author test methods and specifications as needed.
- Initiate and complete QA-Track records when required.
- Sample incoming materials in warehouse. Test and release the incoming materials.
- Monitor laboratory equipment for temperature, humidity, etc., and conformance to specifications
- Must be able to be flexible with work schedule, as needed.
Requirements:
- Bachelor’s degree in 4-year degree in chemistry, health sciences or other related field from an accredited college or university
- A minimum of 3-5 years in a GMP, QC Analytical Techician or in the biotechnology or pharmaceutical industry
- Working knowledge following Standard Operating Procedure (SOP) and anlytical test methods and generally accepted laboratory practices
- Experience in Tech Transfer as well as routine Analytical testing related to Cell/Gene Therapy products.
- Strong verbal and written communication with ability to communicate complex ideas and concepts.
- Strong attention to detail, i.e. reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
- Comfortable with computerized data storage programs such as GLIMs
- Ability to stand on feet for up to four hours at a time;
- Be able to lift, push, and /or pull up to 25 pounds;
- Meet minimal visual acuity requirements necessary for quality assessments
How to Apply
click here and apply| https://smrtr.io/g8tfF |
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