Biopharma QC Lab Systems Analyst | CSV & Instrument

Kelly

Wilson (NC)

On-site

USD 70,000 - 100,000

Full time

9 days ago

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Job summary

Kelly, in partnership with Johnson & Johnson, is hiring a QC Lab Services Analyst (Analytical Instrument and Lab Systems) at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). You will support laboratory equipment lifecycle management and CSV activities.

Responsibilities include qualification of analytical equipment (IQ/OQ/PQ for HPLC, spectrophotometry, endotoxin, cell culture, TOC), SOPs, and integration of technologies like eLIMS/iLABS, Empower, SAP to improve

Qualifications

  • Bachelor's degree in chemistry, biochemistry, microbiology, or a related scientific field.
  • Experience in biopharmaceutical/pharmaceutical industry and QA/document review.
  • Knowledge of regulatory requirements (FDA/EU) and cGMP.

Responsibilities

  • Participate in qualification of analytical equipment (IQ/OQ/PQ for HPLC, spectrophotometry, endotoxin, cell culture, TOC).
  • Author SOPs, work instructions, and protocols.
  • Support QC lab equipment lifecycle management and CSV.
  • Assist introduction of technologies (eLIMS/iLABS, SDMS, Empower, SoftMax Pro, SAP).
  • Collaborate with QC Global org and address instrument and system issues.

Skills

Communication skills
Interpersonal skills
Attention to detail
Independent working
Problem solving
Time management

Education

Bachelor's degree in chemistry, biochemistry, microbiology, or a related scientific field

Tools

eLIMS/iLABS
SDMS
Empower
SoftMax Pro
SAP

Job description

Kelly, in partnership with Johnson & Johnson, is hiring a QC Lab Services Analyst (Analytical Instrument and Lab Systems) at our new Biotherapeutics Manufacturing facility in Wilson, North Carolina (BioNC). You will support laboratory equipment lifecycle management and CSV activities.

Responsibilities include qualification of analytical equipment (IQ/OQ/PQ for HPLC, spectrophotometry, endotoxin, cell culture, TOC), SOPs, and integration of technologies like eLIMS/iLABS, Empower, SAP to improve

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