Job Description

Job Summary

Performs GMP testing of raw materials, in-process and finished products, stability samples, and non-routine sample analyses per established procedures and methodology. Monitors and evaluates systems, equipment, records and trends data. Reviews and revises documentation (i.e. SOPs). Works under limited supervision following established procedures.

Area Of Responsibility

• Perform release, stability, validation, analytical quality control tests and assays on raw materials, in-processing and final products following GLPs
• Perform quality control tests and assays including USP test methods and EP test methods
• Conduct, document and follow up on assay issues, failures and complaint investigations (Trackwise)
• Calibrate, monitor, maintain and evaluate systems and equipment (i.e. water systems, environmental chambers, analytical instrument/equipment)
• Maintain data in manual or computer based logs following GDPs
• Develop, author, and execute instrument IQ/OQ and PQ protocols
• Maintain major laboratory programs (i.e. calibration program, reference standard program)
• Serve as liaison to service, calibration and technical representatives
• Send samples to contract laboratories and collect test data
• Wash glassware, prepare reagents, solutions, equipment for chemical tests and assays
• Maintain laboratory in cGMP compliance and conduct internal lab inspections
• Record and review GMP data, monitor and evaluate QC systems and equipment, recommend improvements to procedures, and revise GMP documentation as required
• Serve as a leader within the QC group and a knowledge resource within the company
• Provide mentoring and training to junior analysts on laboratory tests, skills, and lab processes
• Perform monthly equipment/instrument maintenance and cleaning
• Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
• Train towards Visual Inspection qualifications
• Other duties as assigned

Work Conditions:

• Office
• Lab
• Noise, heat, open flame and radiation in specific areas requiring appropriate safety equipment (i.e. gloves, lab coat, safety glasses and respirator)
• Work with non-hazardous and hazardous chemicals, toxic metals, cryogenic gases and radioactive materials.
• Exposure to or use of syringes and needles
• Requires access/work in chemical fume hoods
• Requires access/work in class 100K, 10K or 100 clean room (mask and boots in conformance with environmental dress codes)

Physical Requirements:

• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Lift up to 25 lbs.
• Operates computer/office machines
• Ability to wear Personal Protection Equipment

Travel Estimate

Up to 5%

Education and Job Qualification

• B.S. or equivalent experience
• Excellent oral and written and interpersonal communication skills
• Fundamental knowledge of chemical principles and analytical instrumentation
• Ability to follow specific instruction (i.e. written SOPs)
• Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
• Proficient knowledge of basic and complex laboratory instrumentation (theory, function, basic and complex troubleshooting)
• Strong analytical skills with attention to detail
• Able to troubleshoot and repair complex instrumentation
• Proficient computer skills including word processing, spreadsheet, and instrumentation control software programs
• Able to perform standard and non-standard analytical techniques to analyze product
• Proficient in use of Balances, Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter, TOC Meter, pH Meter, Autotitrator, Karl Fischer Titrator, High temperature furnaces and oven, Fume hoods, Stirrer/hot plates, Propane burners, Compressed Gas Regulators and Cylinders, Melting Point, Infrared (IR), Gamma Ray Spectrometer and RCP assays, Flame Atomic Absorption (AA), Polarograph, Osmometer, High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC)

Experience

• Minimum 5-7 years of related experience
• Use of Trackwise, Novatech, and Empower software
• Experience with qualitative and quantitative analysis using good analytical laboratory practices
• Working knowledge of cGMP/GLP