Work Schedule

Second Shift (Afternoons)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards

Job Description

The QC Scientist I performs analytical methods for moderately to complex testing on a variety of cleaning, in process, stability, and release samples in a chemistry environment within defined procedures and practices. Support internal manufacturing operations. Make detailed observations and review, documents and communicate test results; recommend solutions.

Typical hours are 3:00pm - 1:30am, Tuesday through Friday, 10 Hour shift

Key Responsibilities:

• Conduct simple chemical and physical testing of pharmaceutical products by internally developed and compendial test methods.
• Complete validated test methods for finished pharmaceutical 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 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.

Qualifications:

• Associate Degree in Chemistry, Biochemistry, Molecular Biology, or related physical/biological service 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.
• Good knowledge of qualitative and quantitative tests.
• Good knowledge 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 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, operating 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.
• PPE:  Safety glasses, safety shoes, lab coat, nitrile or similar gloves, safety aprons, organic respirator occasionally.