Perform standard Quality Control procedures including but not limited to the timely and correct testing of products through the use of multiple platforms including but not limited to: Multiplex, ELISA, RIA and Cell Signaling, data processing and analysis in compliance with ISO 9001 and cGMP regulations to support product release.
ESSENTIAL JOB FUNCTIONS
The following are the primary responsibilities (other duties may be assigned as required):
Who You Are:
- Ability to successfully test and analyze reagents from every platform including but not limited to Multiplex, ELISA, RIA, and Cell Signaling kit reagents (involves calculations, measurements, immunological techniques)
- Ensures the timely completion of work by working with the team and independently
- Ability to multitask is a must, work on multiple product lines within the same day
- Present data to supervisor and/or team lead
- Read and follow SOP’s and protocols
- Highly organized individual able to maintain Quality records and data from the multiple products assigned to test
- Accurate and precise pipetting
- Ensures individual training remains up to date
- Assists in ensuring equipment / instrumentation is in proper working order, and that appropriate training and documentation is up to date
- Good communication skills
- Properly records material and product movement within the ERP system and QC database
- A general understanding of immunoassay principals and Quality Systems
- A general understanding of laboratory procedures
- High school diploma or equivalent required
- Three or more years of Quality Control work experience in a life science manufacturing environment
- Bachelors of Science degree in Biochemistry or Biology strongly preferred
- Three or more years of work experience within a life science manufacturing environment, with scientific knowledge of immunological based biomolecular assays. Practical knowledge in protein chemistry and formulations.
- Familiarity with Operational Excellence-Lean Six Sigma preferred.
- Ability to promote and comply with all Quality System requirements.
- Ability to promote and comply with all Environmental Health and Safety requirements.
- Candidates must be comfortable with excel, and navigating a standard computer
- Physical Demands:
- 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 with or without reasonable accommodations.
- The employee is regularly required to use hands to finger, handle, or feel and reach with hands and arms.
- The employee frequently is required to stand, walk, sit, and talk and hear.
- The employee must occasionally (infrequently) lift and/or move up to 25 pounds.
- Specific vision abilities required by this job include close vision, distance vision, color vision, and ability to adjust focus.
- Work Environment:
- The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job with or without reasonable accommodations.
- The employee may be exposed to toxic or caustic chemicals.
- The employee may be exposed to unknown biological agents.
- The noise level in the work environment is usually moderate.
- The employee may be exposed to cold temperatures.
- The employee may be exposed to a risk of low level radiation.
- Safety Requirements:
- The employee must successfully complete the company’s safety program prior to working in the laboratory which includes:
- Radiation Protection Training Program.
- Chemical Safety Training Program
- Bloodborne Pathogen Training Program