Essential Duties and Responsibilities

• Acts as a key contact to E&R, as well as Quality Control, Analytical Development, and Process Development for; equipment and instrumentation maintenance, calibration and qualification requirements.
• Initiate, conduct, and close out change controls for updates/ installation of laboratory instrumentation and using Electronic Data Management System (MasterControl).
• Schedules and coordinates maintenance service calls, to ensure appropriate departments are notified, supplies are ready, the timeline is set, and required paperwork is complete.
• Documents and maintains excellent records, following ALCOA guidelines, such as daily maintenance logs, monthly reports, work orders, and other reports as required.
• Perform monthly analytical balance repeatability and eccentricity checks.
• Write instrument PQ/OQ/IQ Out of trend /Out of specification reports and investigate root cause for OOS/OOT.
• Participate in regulatory and partner audits as required.
• Author CAPAS, COOTS, and SCARS as needed for instruments/ equipment.
• Act as departmental system administrator for various instrument software: i.e. Topspin, Empower, Chemstation, etc.
• Order chemicals and supplies for analytical laboratories, as needed. 

Minimum Qualification Requirements

• An Bachelor’s degree in Biology, Chemistry or other relevant scientific degree.
• 2+ years of experience working in the Pharmaceutical, Biotechnology or other related industry is highly preferred.
• Familiarity and general understanding of HPLC, NMR, GC and other laboratory equipment, a plus
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, procedures manuals, and blueprints is required.
• Strong attention to detail is a must.
• Good communication skills both oral and written are a must.
• Good computer skills are required.
• Working knowledge of MS Word, Excel, and PowerPoint is required.
• Excellent organizational skills are required.
• Previous experience working in a GMP or GLP environment is preferred.

Physical Requirements

• Must be able to pass pre-employment drug screening and background check for employment consideration.  
• Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function.
• Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Performance of tasks essential to the job function may require the employee to work directly with, handle, or otherwise come into contact with chemicals or pharmaceutical agents.
• Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function. Employees must be able to maneuver themselves under 30 inch clearances.
• Employees must be able to able to detect color accurately and have 20/20 vision (with/without corrective lenses).
• Employees may be required to enroll in a medical surveillance program based on the potential exposure to certain health hazards encountered as a result of their job function.