QC Technologist

Job Description

Job Summary:

• A successful person will perform Environmental Monitoring tasks in support of Sterile 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 Product knowledge of aseptic gowning as well as working in cleanrooms in order to monitor the area while sterile products are filled and manufactured.

Duties & 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 Client 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.

Required Qualifications:

• High school diploma including laboratory work in a science discipline.
• An associate’s degree in a science related field, preferably Biology, is preferred.
• Relevant post-secondary educational courses are considered.
• 1 year related experience preferred performing lab bench work including utilizing instrumentation and reporting data.
• Knowledge of aseptic techniques.
• Knowledge of MS Excel and Word 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 enProducts 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) are required.
• Ability to apply mathematical operations.

Physical Requirements:

• Position is primarily focused on production line support which involves 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.
• This position also requires ordinary ambulatory skills and physical coordination sufficient to move about environmental lab.