Biotech Quality Control Analyst - GMP Lab Onsite

ApTask Global Workforce; Frederick (MD); On-site; USD 34,000 - 49,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Sick Pay

Job summary

Aptask Global Workforce (AGW) seeks a Quality Control Analyst for an onsite, 6+ month contract with a Global Biotechnology Company in Frederick, MD. Test raw materials, intermediates and final products in a GMP laboratory using Flow Cytometry, ELISA, qPCR and cell-based bioassays.

Training lasts 7 weeks (Mon-Fri, 7:30 AM-4:00 PM) followed by Wed-Sat shifts (7:00 AM-5:30 PM). Requirements include a Bachelor’s or AA with QC biotech experience, or HS with QC experience.

Qualifications

• Bachelor’s Degree OR AA with 2+ years QC experience in biotech.
• High School Degree with 3+ years QC experience.
• Quality control experience and GMP knowledge.
• Experience in investigations of OOS results.
• Proficient in MS Word, Excel, PowerPoint.
• Strong written and verbal communication.
• Experience with Flow Cytometry, ELISA, qPCR.

Responsibilities

• Test raw materials, intermediates, and final products using approved methods.
• Maintain lab in optimal state with internal/external resources.
• Review test data and documents for in-process testing and release.
• Provide information to support CoA generation.
• Maintain laboratory instruments and calibration.
• Write or revise SOPs and validation documents.
• Investigate OOS results and determine root cause.
• Provide updates at daily/weekly meetings.
• Monitor GMP systems for policy compliance.
• Review proposed changes to systems and methods for regulatory submissions.
• Gather metrics for continuous improvement.

Skills

GMP knowledge

OOS investigations

Analytical techniques

Communication skills

Independent work

Flow Cytometry

ELISA

qPCR

Cell-based assays

Biotech/pharma experience

Education

Bachelor’s Degree

AA Degree + 2+ years QC

High School Degree + 3+ years QC

Tools

MS Word

Excel

PowerPoint

Job description

Aptask Global Workforce (AGW) seeks a Quality Control Analyst for an onsite, 6+ month contract with a Global Biotechnology Company in Frederick, MD. Test raw materials, intermediates and final products in a GMP laboratory using Flow Cytometry, ELISA, qPCR and cell-based bioassays.

Training lasts 7 weeks (Mon-Fri, 7:30 AM-4:00 PM) followed by Wed-Sat shifts (7:00 AM-5:30 PM). Requirements include a Bachelor’s or AA with QC biotech experience, or HS with QC experience.