PURPOSE AND SCOPE

Coordinates stability programs and facilities. Reviews for completeness, verifies and enters stability data into the stability database when received from the QS Laboratory Groups. Assists in laboratory quality and validation projects including special analyses and stability studies.

PRINCIPAL DUTIES AND RESPONSIBILITIES

Reviews notes and test methods and compare information with final reports to detect errors and ensure completeness and conformity to SOPs and regulatory guidance. Coordinates drug and device stability studies. Coordinates stability chamber space and environmental conditions, including product levels and mechanical maintenance. Maintains data base and spreadsheets. Assists the drug/device laboratories with stability testing using various techniques as required by respective projects based on current training and capabilities. Compares input and output data and calculations for correctness. Assists in stability study maintenance projects and laboratory quality improvement projects. As required by stability SOP's and protocols, loads and pulls stability samples into/from the stability chambers. Delivers samples to the respective testing laboratories testing. Gathers and reviews data related to stability testing and compiles into respective study files. Enters respective data into the stability database for review and approval. Works closely with the Stability Scientist II on stability-related issues/projects. Maintains general housekeeping of working area, environmental chambers and proximal plant areas. Builds stable working relationships internally. Normally receives specific, detailed instructions on all work. May refer to senior staff, if applicable, for assistance with day-to-day problems that may arise. Escalates issues to Stability Scientist II, supervisor or manager for resolution, as deemed necessary. Assist with various projects as assigned by direct supervisor. Other duties as assigned. Drug Stability Duties Coordinates drug stability studies. Oversees drug product levels and inventories. Compiles and submits Annual Drug Product Review data to respective ADPR team leaders. Monitors drug environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions. Performs chamber reprofiles for drug chambers as required. Assures annual (ongoing) stability lots are pulled and placed into stability yearly as specified in the applicable SOP. Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements. Device Stability Duties Coordinates device stability studies. Oversees device product levels and inventories. Provides device-related stability reports and data to respective study leaders as required. Monitors device environmental storage conditions. Assures proper environmental chamber operation and maintains environmental conditions. Performs chamber reprofiles for device chambers as required. Performs annual test method, instrument qualification and software validation reviews in accordance with the respective PM requirements. Additional responsibilities may include focusing on one or more departments or locations. See applicable addendum for department or location specific functions.

PHYSICAL DEMANDS AND WORKING CONDITIONS

The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Regularly required to use hands and fingers to handle and talk or hear. Frequently required to stand; walk; sit; reach with hands and arms and wear personal protective equipment that may include Safety glasses, etc. Occasionally required to climb or balance and stoop, kneel, crouch, or crawl. Must frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Occasionally exposed to wet and/or humid conditions; moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals and risk of electrical shock. The noise level in the work environment is usually moderate. ​

EXPERIENCE AND REQUIRED SKILLS

Bachelor's degree in chemistry or closely related science field required Minimum 1 - 2 years' stability or laboratory related experience. Ability to read, analyze, and interpret general business periodicals, professional journals, science journals, technical procedures, or governmental regulations. Strong oral and written communication skills. Ability to apply advanced mathematical concept Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists Proficient with PC operating systems, windows a plus Experience in Microsoft Office applications. Knowledge in cGMP, Drug and device processes a plus. Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.