Participate analytical method development, validation, and verification activity as per current requirements.
Prompt testing of experimental batches for timely product development.
Timely testing and release of intermediates and drug products in compliance with current GMP practice.
Work on respond to Information Request (IR) and Complete Response (CRL) Letters in timely manner.
Increase the analytical and scientific knowledge transfer to Quality Control laboratories for their better understanding of the methods to be transferred.
Completion of analytical method transfer activities on a timely manner and with the highest quality standards.
Compliance with government regulations, GMPs, and company policies.
Ensure compliance with all company policies and procedures, including safety rules and regulations.
Meet site EHS requirements (hazard reporting, safety trainings, laboratory inspections).
Required Skills:
Bachelor' s in science (B.SC.) or higher.
Previous experience: Minimum 5 years.
Software experience: MS Office and Empower.
Previous pharmaceuticals experience a plus, but recent experience in dissolution using HPLC is a must.
MS Office.
Lift 25 lbs.
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Anita: anitaj@alphaconsulting.Com
ALPHA' S REQUIREMENT #22-03164
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
