Position Summary

The incumbent will be responsible processing human birth tissue in an FDA regulated environment and following all cGMP requirements.

Essential Duties & Responsibilities

• Responsible for aseptic processing of birth tissue in a cleanroom environment, including processing area set up and change over as needed.
• Responsible for aseptic preparation of solutions used for processing.
• Responsible for maintaining aseptic and neat work environment.
• Responsible equipment cleaning and general equipment maintenance.
• Responsible for data entry.
• Record data following cGMP requirements.
• Complete requisitions for test samples and submit to the designated labs for testing.
• Responsible for executing production controls (e.g., inspection steps) to ensure product quality standards are met.
• Responsible for ensuring that materials and processes follow FEFO (first expire first out) and that processes are completed within validated parameters.
• Assist with troubleshooting process issues and notify supervisor of unusual problems (i.e., potential deviations, problems with equipment or materials).
• Responsible for handling Biohazard waste and following all safety guidelines.
• Prepare disinfectants and perform facility sanitization/cleaning as necessary.
• Perform general office duties such as: filing, typing, labeling, copying and shredding confidential documents.

Position Expertise/Qualifications

• High school diploma or equivalent required
• Bachelors or associates in biological sciences, or a related field preferred.

Minimum Years of Experience

• 1-3 years laboratory experience preferred
• 1-3 years cleanroom experience preferred

Skills & Abilities

• Excellent communication skills, fluent English oral and written
• Ability to multi-task, setting priorities effectively to produce quality work in a fast-paced professional environment
• Ability to follow verbal direction and to understand written policies, guidelines, specifications, and safety standards.
• Self-motivated, results-oriented, forward thinker that takes initiative to make things happen, accepts accountability, and work with minimal supervision.
• Basic proficiency in Microsoft software applications (i.e., Excel, Word, PowerPoint, and Outlook) is required.

Travel Requirements

Essential Physical Requirements

• Standing and walking: more than one-fourths of the workday.
• Sitting: more than three-fourths of the workday.
• Hearing: more than three-fourths of the workday.
• Vision: more than three-fourths of the workday.
• Communication, verbal: more than one-tenth of the workday
• Communication, written: more than one-fourth of the workday.
• Ability to lift up to 10 lbs.: up to one-fourth of the workday.
• Ability to lift up to 25 lbs.: seldom, up to one-tenth of the workday.

Environmental Conditions