Quality Control Analyst

JMD Technologies Inc.; Boston (MA); On-site; USD 55,000 - 69,000; Full time

Job summary

JMD Technologies Inc. is seeking a Quality Control Specialist to support analytical functions in the QC department, including validation, testing, and reporting of in-process, release, and stability samples.

The role ensures activities are conducted efficiently and in a cGMP compliant manner. Responsibilities include executing tests (flow cytometry, cell counting, culture, sterility, endotoxin, and Visual Inspection), reviewing data, and maintaining records both on paper and electronically.

Qualifications

• Bachelor's degree in a related science is required.
• 2–6 years of GMP pharmaceutical/biopharmaceutical experience.
• Experience with multiple listed methodologies in QA labs.

Responsibilities

• Supports validation, testing, and reporting of in-process, release, and stability samples.
• Performs technical reviews of raw data and records test results.
• Maintains raw data and laboratory records in paper and electronic systems.
• Performs general lab and equipment maintenance duties.
• Troubleshoots analytical methods and participates in Quality Events (Deviations, OOS).

Skills

cGMP compliance

lab equipment knowledge

LIMS experience

attention to detail

teamwork

Excel/Word proficiency

adaptability

Education

Bachelor's degree in biology/chemistry/biochemistry

Tools

LIMS

Electronic instrument software

Job description

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.