- Assist with quality control analytical testing of samples provided to the QC laboratory.
- Assist with executing test qualification and validation of QC test methods
- Writes and revises Standard Operating Procedures (SOPs) and other related Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP) documentation
- Manages test samples, reagents and reference standards
- Provides QC support for the Sample receipt for Manufacturing
- Perform other duties as assigned.
Required Skills & Abilities:
- Working knowledge of ELISA based methods, cell based assays and qualification of critical reagent methodologies.
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Utilize SDS sheets to properly assess chemical hazards, spill response procedures, and PPE requirements if indicated.
- Excellent attention to detail.
- Computer proficiency required.
- Ability to accurately complete required documentation.
- Excellent written and oral communication skills.
- Excellent organization and analytical skills.
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:
- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Ability to lift up to 15 lbs regularly and up to 30 lbs on occasion.
- Potential for exposure to hazardous chemicals, gases, fumes, odors, mists, and dusts, and other hazardous materials.
- Ability to wear personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required in most areas associated with this position.
- Attendance is mandatory.
- Undergraduate degree in Biology or science related field; OR
- AAS in biology or science related field and 2 years of experience.
- Analytical laboratory experience in a GLP/GxP or a comparable federally regulated environment.