PRIMARY DUTIES AND RESPONSIBILITIES:
- Perform analytical tests (wet chemistry, assay, impurity/degradant, dissolution and residual solvents in raw materials and finished products according to USP or in-house methods.
- Perform method validation/verification for API and drug products.
- Comply with cGMP regulations and follow all standard operating procedures or with manager’s instructions.
- Maintain and troubleshoot laboratory equipment and analytical instrumentation within level of experience.
- Review peer’s notebooks.
- Coordinate with Quality Control department to smoothly transfer the methods.
- Work with Sr. chemist to write method validation protocols and reports.
ASSOCIATED DUTIES AND RESPONSIBILITIES:
- Perform and/or assist with equipment calibrations and qualification
- Other related duties as required.
REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:
(INCLUDE LEVEL OF EDUCATION, YEARS / TYPE OF EXPERIENCE, CERTIFICATIONS, ETC.)
- 4 year degree in chemistry or related discipline.
- 2 – 4 years experience with analytical instrumentation, such as HPLC/ GC and dissolution apparatus.
- Ability to follow standard operating procedures.
- Solid working knowledge of MS Office programs.
- Strong communication skills, both written and verbal.
- Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
- Strong attention to detail.
- Desire and ability to work in a positive team environment.