Quality Control Scientist

United Pharma; Massachusetts; On-site; USD 50,000 - 70,000; Full time

Job summary

A pharmaceutical company located in Massachusetts is seeking a laboratory technician to conduct ELISA-based testing and manage routine laboratory tasks. The ideal candidate will have proven experience with ELISA techniques and GLP/GMP compliance. Responsibilities include troubleshooting under the guidance of a manager and ensuring proper documentation of data. The role requires someone who is highly organized, detail-oriented, and efficient in a fast-paced team environment.

Qualifications

• Proven experience with ELISA techniques.
• Experience with GLP and/or GMP documentation practices.
• Strong attention to detail.

Responsibilities

• Conduct routine sample testing using HCP ELISA-based assays.
• Manage assigned tasks, analyze and interpret test results.
• Support laboratory and equipment maintenance.

Skills

ELISA techniques

Attention to detail

Effective teamwork

Tools

Microsoft Word

Microsoft Excel

SoftMax Pro

Job description

• Conduct routine sample testing using host cell protein (HCP) ELISA–based assays.
• Manage assigned tasks, analyze and interpret test results, and perform troubleshooting under the guidance of a manager.
• Train and assist with non-GMP sample testing for company programs. Ensure timely and accurate documentation of data in accordance with departmental policies using data packets or electronic lab notebooks (GLP-compliant documentation).
• Support routine laboratory and equipment maintenance to ensure compliance and proper operation. Experience in a QC laboratory environment is considered an advantage.
• Work collaboratively in a fast-paced, team-oriented environment.

Scope of Work

• Perform ELISA plate-based testing for approximately 300 samples as part of a process characterization study.

Required Qualifications

• Proven experience with ELISA techniques.
• Experience with GLP and/or GMP documentation practices.
• Strong attention to detail.

Preferred Qualifications

• Experience in developing or testing host cell protein (HCP) or impurity-based ELISA assays.
• Experience working in a QC laboratory or GMP environment.
• Proficiency in Microsoft Word, Excel, and PowerPoint, along with experience using plate-based software such as SoftMax Pro.
• Highly organized, efficient, and able to work within established timelines while contributing effectively as part of a team.