ABOUT IMPRIMISRX

At ImprimisRx, we are working hard to be the most trusted company in ophthalmic pharmaceutical compounding. To get there, we need exceptionally talented, bright, and driven people. If you would like to help us build a quality culture organization trusted by eye healthcare professionals from across the US, this is your chance to join us. We are looking for a high energy, dynamic, organized self-starter to join our Quality Department.

JOB SUMMARY

This position will assist with the QC samples, including raw materials, stability and finished drug products. This position has to do Daily temperature and RH monitoring of stability chambers, study request for selected study, initiate/load stability samples in the stability chamber, create study files in the software, pulled samples from stability chamber as per pull schedule. Raw materials, stability and finished drug products sample send out for testing at laboratories with appropriate documentation (In-house, CIAL, Focus, Biolink, HAS…etc.) and follow-up for results, maintain sample storage space (keep arranging samples up on pull to make more room for upcoming new studies), maintain stability sample inventory by updating iStability software, enter result in the iStability software and transcribe data in FP, RM spec upon received CoA’s from testing laboratories, generate stability summary reports as needed, perform regression analysis report as needed and create/revise Stability Protocols, Stability specifications and Finished Product specifications as needed. Also, update tracking file to keep up to date information for testing status of each sample sent out for testing.

QUALIFICATIONS & REQUIREMENTS

· Bachelor’s Degree in scientific discipline preferred.
· 5 years of pharmaceutical laboratory environment experience; or equivalent combination of education and experience.
· Must be computer literate, with experience in spreadsheet and database applications
· Must be detail oriented
· Must be well organized
· Must have the ability to work on multiple different tasks within a workday
· Must have a positive teamwork attitude
· Excellent interpersonal, oral, and written communication skills
· Maintains confidentiality of sensitive information
· Ability to meet attendance standards. All full-time employees are required to minimally work a 40-hr week. Sometimes it may be necessary to work additional hours to accomplish the required tasks to meet deadlines

· Handles all QC samples, including raw materials, finished drug products, and stability samples, for submission to appropriate analytical testing laboratories, including making out submission paperwork or entry forms and shipping the samples to outside laboratories
· Enters all raw material and finished drug product sample information into the sample management software
· Enters anticipated dates for QC release of testing data into disposition tracking software
· Enters all stability sample information into the stability management software
· Pulls raw material, finished drug product, and stability testing data from data repositories
· Follows up with laboratories on past due test results
· Enters raw material and finished drug product test results into the sample management software
· Prepares executed test specifications for raw material and finished drug product testing
· Prepares stability protocols
· Enters stability test results into the stability management software
· Creates stability reports
· Provides stability data and analysis for Annual Product Quality Review (APQR) reports.
· Orders, receives, logs, disposes of, and maintains inventory of reagents, samples, standards, supplies, etc., as per applicable procedures and make them available for in-house laboratory usage
· Other duties will be assigned as required to support QC and Quality