Main Responsibilities and Accountabilities
1. Responsible for the regulatory and scientific conduct of development, validation of quality control methods and other specialty projects.
2. Routinely acts as the technical project leader for multiple projects, interacts with clients to provide updates, reviews and evaluates data, writes reports and protocols.
3. Qualifies new lab instruments against lab procedures and validates accurate results to be used for routine testing.
4. Experience writing and performing validation plans and reports for FDA approved methods.
5. Follow analytical method validation requirements and guidelines including the USP, EP and ICH.
6. Working knowledge to perform method testing and validation for new testing. Ability to calculate and interpret data and record data in adherence with SOPs and any additional requirements specific to the lab.
7. Maintains working knowledge of current regulations and guidelines related to method validation.
8. Performs development, validation, and maintenance of laboratory methods to ensure a constant state of compliance.
9. Evaluates invalidity rates and analytical trends. Suggest resolutions to QC management.
10. Assesses performance of analytical instruments and equipment and recommends new acquisition or replacements. Provides release of new laboratory equipment to routine testing ensuring that the method validation status is maintained.
11. Supports investigations into facility deviations with appropriate testing and interpretation of the analytical results.
12. Ability to independently perform root cause analysis for method investigations.
13. Working knowledge of common central laboratory instruments and operating systems if highly preferred.
14. Completes any other duties/responsibilities assigned by senior management.
Education: BS/BA degree or equivalent in appropriate science
Experience: 7 years with 1-3 years in method development in related field recommended. Proven demonstration to perform in the role may also be considered.
Possesses a thorough knowledge of quality systems
Superior abilities relevant to the laboratory
Independent working skills
Exhibits expertise in analytical areas
Effective written and oral communication skills
High level of technical training
Share:State/ProvinceIllinoisCityKankakeeStreet Address1201 N. KinziePrimaryLocationCSL Behring Kankakee
Equal Opportunity Employer
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