Work Schedule

10 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials

Job Description

QC Scientist I

The QC Scientist I perform 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.

Key Responsibilities:

• 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 following cGMP's.

• 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.

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.

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. Arm, hand and finger dexterity, including ability to grasp and type. Visual accuracy to use a keyboard, computer monitor, operate equipment, and read materials. 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.