Quality Control Analyst

JMD Technologies Inc.; Boston (MA); On-site; USD 55,104 - 68,880; Full time

Job summary

JMD Technologies Inc. in Boston seeks a Quality Control Analyst to support QC operations on the 3rd shift, helping validate, test, and report on in-process, release, and stability samples in a cGMP environment.

The role emphasizes meticulous data handling, adherence to cGMP and cGDP, and collaboration with the team to troubleshoot methods and maintain electronic records. Experience with LIMS and lab software is preferred, and the successful candidate will work closely with QA, manufacturing, and

Qualifications

• Bachelor's degree in biology, chemistry, biochemistry, or related science.
• 2–6 years of GMP pharmaceutical/biopharmaceutical experience.
• Demonstrated laboratory experience in multiple methodologies listed in responsibilities.

Responsibilities

• Perform tests including flow cytometry, cell counting, cell culture, sterility (BACT), endotoxin (LAL), and Visual Inspection.
• Submit technical reviews of raw data.
• Record test results and maintain raw data and accurate lab records.
• Perform general lab and equipment maintenance duties.
• Take part in troubleshooting analytical methods and Quality Events (Deviations, OOS).
• Adhere to cGMP and cGDP principles and maintain equipment and notebooks.

Skills

Attention to detail

Team player

cGMP knowledge

Data handling

Laboratory basics

Electronic lab notebook (LIMS)

Education

Bachelor's degree in science

Tools

LIMS

Job description

Title: Quality Control Analyst - 3rd Shift

Status: Accepting Candidates

About the role

The Quality Control Specialist is responsible for supporting a variety of analytical functions that occur in the Quality Control (QC) department supporting validation, testing, and reporting of in-process, release, and stability samples. This role also helps ensure activities occur in an efficient and cGMP compliant manner.

Responsibilities

• Typical test methods performed include, but are not limited to, flow cytometry, cell counting, cell culture, sterility (BACT), endotoxin (LAL), and Visual Inspection testing.
• Performs technical reviews of raw data.
• Records test results and maintain raw data and accurate laboratory records on paper and in electronic systems.
• Performs general lab and equipment maintenance duties.
• Performs other duties as assigned.
• Troubleshooting analytical methods and participating in Quality Events (Deviations, OOS)

Knowledge and Skills

• Performs tasks with strict adherence to cGMP and cGDP principles.
• Has an understanding of basic laboratory equipment and practices.
• Is proficient in the use of spreadsheets and word processing software.
• Is dependable and able to work well within a team.
• Is interested in learning new things. Open to change.
• Is optimistic and displays a positive attitude even during periods of adversity.
• Shows initiative; acts independently with management approval.
• Possesses a high attention to detail.
• Experience with electronic lab notebook (LIMS), and demonstrated ability to work with electronic instrument software

Qualifications

• A minimum of a Bachelor's degree in related field of science is required (Biology, Chemistry, Biochemistry, etc).
• 2-6 years of experience in the GMP pharmaceutical/biopharmaceutical industry
• Demonstrated laboratory experience in multiple methodologies listed above

Compensation (MA Pay Transparency)

• $40–$50/hr (W-2)
• Final rate within the posted range depends on qualifications and interview outcomes.