QC Scientist I (release and stability testing)

at  Thermo Fisher Scientific

JOB DESCRIPTION

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers
an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

GROUP/DIVISION SUMMARY

The Drug Product Division - North America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The QC Scientist I performs analytical methods for moderate to complex testing on a variety of stability and release samples in a chemistry environment within defined procedures and practices. This position supports internal manufacturing operations for sterile products. The analyst makes detailed observations and reviews, documents and communicate test results; recommend solutions. Typical hours are 8:00pm - 4:30pm, Monday through Friday.

QUALIFICATIONS:

• Associate Degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological science field minimally required. Bachelor degree preferred.
• 1+ years related experience performing chemical tests with chromatographic, spectroscopic, or other analytical techniques, working knowledge of EMPOWER is a plus.
• Good knowledge and understanding of chemistry and analytical instrumental technologies.
• Familiar with qualitative and quantitative chemical analysis.
• Knowledgable of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs.
• Good problem-solving skills and logical approach to solving scientific problems.
• Good interpersonal and communication skills (both oral and written).
• Ability to apply mathematical operations.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time. Manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds. Arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for
prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety apron, organic respirator occasionally.

• Conduct simple chemical and physical testing of pharmaceutical products by internally developed and compendial test methods.
• Complete validated test methods for pharmaceutical finished products and traditional wet chemical testing.
• Recognize and report out-of-specification or unexpected results and non-routine analytical and product problems.
• Clearly and accurately communicate the results of work by documenting the testing/analysis and obtained results.
• Record and report results of analysis in accordance with prescribed lab procedures and systems.
• Provide communications with outside departments.
• Write SOPs and other instructional documents.
• Clean and organize work area, instrumentation, and testing materials.
• Perform all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintain the necessary compliance status required by company and facility standards.