QC Specialist I - Temporary Non-Employee

Overview

The Quality Control Group is looking for new talent to join their multifunctional team to support manufacturing activities. This position involves routine testing and logistical activities in the Bio-Plex QC Group. You will execute core laboratory testing involving biotinlyation, conjugation, and immunoassay.

 

Other duties would include assisting with laboratory and general maintenance to support compliance to ISO13485 regulations standards. The incumbent will ensure the adherence to documentation requirements and interact with peers and collaborating with cross functional teams as needed.

 

A typical day will involve completion of testing on assigned batches and completing paperwork/data entry into SAP to document results for review/product release. This role requires communication and coordination between team members, the supervisor, the planners, and any other cross functional teams to ensure that we are keeping on top of priorities to avoid backorder and prevent stock out.

 

Work hours 8 am - 5 pm Monday to Friday

 

• Support Quality Control activities towards Bio-Plex Group’s products lines.
• Perform QC testing on incoming and manufactured materials to support release into inventory.
• Document testing activities and results accurately following good documentation practices to ensure adherence to ISO13485 requirements.
• Inform supervisor of any deviations from process and perform follow up actions as needed.
• Participate in troubleshooting activities with guidance from relevant sources as needed.

How you will make an impact:

• Contribute to timely product release to meet the business goals to deliver product to customers on time by completing assigned tasks on time.
• Communicating technical issues and concerns promptly to escalate/establish root cause to move the process forward.
• Cross-training on our vast portfolio of processes to learn new lab skills in QC while supporting equitable workload distribution and efficient product release.
• Identify areas for improvement in QC processes/procedures and execute projects to implement changes.
• Work on exciting new product implementation projects to train on and transfer robust processes for future QC testing of products.

Qualifications:

 

• Education: Bachelor's degree or equivalent in a life science (Chemistry, Biology) or related field.
• Work Experience: 0-2 years in a general laboratory environment performing analyses in the areas of chemistry, biochemistry, or associated areas of life sciences, or equivalent combination of education and experience.
• Understands and can apply GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).
• Strong computer skills, including Microsoft suite.
• Experience with ERP systems a plus, SAP preferred

 

$70,310 - $85,300 annually