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
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.
Location:Parsippany, New Jersey
How to Apply
click here to apply| https://smrtr.io/g8tfF |
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