QC Technician I

Job Description

Job Summary:

• Perform & review analysis of in-process, release & stability samples of API and/or filled product in accordance with cGMP, site & corporate policies & procedures.

Duties and Responsibilities:

• Accuracy & Scientific Soundness of Lab Data.
• Environmental Compliance.
• GMP Compliance of Laboratory.
• Maintain testing proficiency for methods.
• Timeliness of Lab Results & Investigations.
• Operational support of the QC Laboratory.
• Support of DAPI US & DFP water testing program.
• Support of Lab Preventative Maintenance program.
• Other accountabilities, as assigned.

Education and Experience:

• Associate’s Degree in a scientific field or equivalent combination of education & relevant experience preferred.
• Minimum of one (1) year of experience in a clinical or industrial/pharmaceutical laboratory a plus.

Knowledge, Skills, and Abilities:

• Preparation of Microbiological media.
• Washing and sterilization with autoclaves of equipment and media.
• Reading and interpretation of Environmental monitoring samples.
• Bioburden testing of utilities samples via membrane filtration.
• Able to perform routine testing per SOP & GMP standards a plus.
• Knowledgeable in basic laboratory techniques a plus.
• Must demonstrate attention to detail preferred.
• Strong communication skills (verbal & written) a plus.
• Ability to execute testing according to a structured plan a plus.

Top Skills:

• Preparation of Microbiological media.
• Washing and sterilization with autoclaves of equipment and media.
• Reading and interpretation of Environmental monitoring samples.
• Bioburden testing of utilities samples via membrane filtration.

Physical Requirements / Work Environment:

• Moves equipment &/or supplies weighing up to 33 pounds within the facility using various body positions.
• Ability to do close precision work with their hands.
• Must be able to remain in a stationary position (sitting and standing) 50% of the time.
• Requires corrected vision to 20/25
• Requires color vision.
• Occasionally ascends/descends a ladder.
• May be required to work at elevated heights.
• Occasionally works around odorous &/or hazardous materials.