This position is located in Billerica, Massachusetts.
Performs various quality control tests on raw materials, in-process and final product using established Standard Operating Procedures (SOPs) and working in accord with current Good Manufacturing Practices (cGMPs)
Area of Responsibility:
- Performs analytical quality control tests and assays for release, stability, and complaint follow-up on raw materials, in-processing and final products.
- Performs the quality control tests and assays and monitors equipment (i.e. water systems, environmental chambers). Maintains records of the data in manual logs.
- Wash glassware/prepare reagents, solutions, and equipment for chemical tests and assays.
- Basic training in use of Single Wavelength Ultraviolet/Visible (UV/VIS) Spectrometer, Conductivity Meter, pH meter, Dissolved Oxygen Analyzer, Karl Fischer Titrator, High temperature furnaces and oven, Fume Hoods, Stir/Hot Plates, Propane Burners, Compressed Gas Regulators and Cylinders
- Good oral and written communication skills and ability to use these skills to follow specific instruction and report assay results (i.e. written SOPs)
- Proficient with wet chemical methods and tests (USP, ACS, Titration, Limit tests, etc.)
- Fundamental knowledge of chemical principles
- Proficient with basic laboratory instrumentation
- Basic computer skills
- Works under general supervision following established procedures
- Lab environment with moderate 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 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)
- 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 10 lbs.
- Operates Computer/office machines
Education and Job Qualification :
- BS in related scientific major
- Minimum 0-2 years related experience preferred