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Scientist, Extractables Jobs
Company | West Pharmaceutical Services |
Address | Exton, PA, United States |
Employment type | FULL_TIME |
Salary | |
Category | Medical Equipment Manufacturing,Packaging and Containers Manufacturing,Pharmaceutical Manufacturing |
Expires | 2023-08-15 |
Posted at | 10 months ago |
Description
- Other duties as assigned.
- Follow required cGMP regulations and internal QA procedures.
- Independently complete routing testing projects from initiation through completion with minimum or without supervision.
- Author basic work instructions, SOPs, and qualification documentation.
- Possess ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude.
- Provide training on basic established techniques and/or test methods
- Willingness to learn and apply new analytical techniques.
- Make rational and sound decisions at an individual level.
- Meet individual and departmental goals and metrics.
- Review protocols and reports as required.
- Participate in and complete simple lab investigations, OOS, and OOT as required.
- Adhere to established laboratory safety procedures.
- Actively participate in and complete all appropriate training tasks in a timely manner.
- Proficient with HPLC, GC-FID, IC and/or ICP-OES, Empower software and routing sample testing methods while following standard operating procedures (SOPs).
- BS in Chemistry or related technical degree.
- Advanced Degree is preferred.
- Minimum 3 years in a related field and a cGMP environment.
- Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this
- CGMP
- Working knowledge of method development and validation on drug product and container closure system.
- Able to comply with the company’s quality policy at all times .
- Able to comply with the company’s safety policy at all times
- USP/EP and ISO compendia
- Support and contribute to Lean Sigma programs and activities towards delivery of the set target
- Working knowledge of Mass spectrometry instrument, such as LCMS and GCMS.
- Working knowledge of Extractables and Leachables.
- Comfortable in oral and written communication, able to present results and conclusion in both manners.
- Must be able to travel up to 5% of the time
- Employee may be required to lift heavy objects (up to 25 lbs.) without assistance
- Job-related activities that require a mental skill or ability such as communication, quick decision making, interpreting data, reading or writing, public speaking, etc. (e.g., Must be able to express or exchange ideas with employees; Must be able to understand direction and adhere to established procedures)
- Effective dexterity to operate objects, tools, or controls and reach with hands and arms.
- Job-related activities that require a physical activity such as standing in laboratory environment
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