QC Scientist I

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

A successful person will perform Environmental Monitoring tasks in support of Steriles production within classified areas. The individual is encouraged to follow the 4i Values that are held in high regards by the company when completing their work. The four values are integrity, innovation, intensity, and involvement. The job function includes aseptic technique which requires the individual to gain knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured. Typical shift hours are 6pm-6am on a 2-2-3 rotating schedule.

Key Responsibilities:

· Perform analyses including instrumental and automated methods using prescribed procedures and techniques.

· Generate valid data, report results on appropriate database compared to established specifications while adhering to GMPs.

· Compare laboratory results with specifications for acceptability and determine if repetition or OOS is required.

· Maintain equipment and troubleshoot instrumentation problems, procedural problems or production problems.

· Review and understand SOPs and analytical procedures as needed.

· Schedule activities to meet target dates for customer needs.

· Follow all job-related safety and other training requirements.

· Performs tasks as assigned by area supervision or designee.

· Able to withstand extended periods of standing and/or walking and bending.

Qualifications:

· Bachelor’s degree in a Biology/ related field is preferred. An associate's degree in a science related field, preferably Biology, is minimally required.

· 2 years of related experience preferred, performing lab bench work using instrumentation and reporting data.

· Knowledge of MS Excel, Word, and Access and is familiar using each program.

· Excellent problem solving and critical thinking skills are a plus when performing this job.

· Organization and detailed planning skills are seen as major pros for this job function.

· Strong attention to detail and ability to follow standard procedures

· As our supported area of the company is a fast paced environment a person who enjoys a constantly evolving environment will do well.

· Good knowledge of quality and regulatory requirements in the pharmaceutical industry, including pharmaceutical GMPs are a plus.

· 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, squat, crouch periodically for prolonged periods of time. Ability to lift, carry, and/or move light to medium weights of 25-50 pounds, occasionally pushing or pulling 50-100+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.