Analytical Quality & Change Control Specialist

JMD Technologies Inc.; Boston (MA); On-site; USD 83,000 - 90,000; Part time

Job summary

JMD Technologies Inc. in Boston seeks an Analytical Quality & Change Control Specialist to support GMP quality activities, focusing on Change Control, analytical data review, investigations, CAPA, and quality systems.

You will work with analytical laboratories and cross‑functional teams, applying methods like HPLC, GC, chromatography and spectroscopy, and utilizing Veeva or other eQMS platforms to manage documents and quality records.

Qualifications

• Bachelor's degree in a scientific or allied health field preferred; equivalent relevant experience may be considered.
• Strong experience with Change Control and analytical testing in a GMP environment.
• QC and/or QA experience with a focus on quality systems.
• Analytical laboratory experience with HPLC and data review.
• Experience supporting investigations, CAPA, and root cause analysis.
• Experience with Veeva or other eQMS/document management platforms.
• Experience working with CMOs/CTOs and cross‑functional teams.

Responsibilities

• Manage and support Change Control activities within a GMP environment.
• Apply QC/QA experience with an emphasis on quality systems and Change Control.
• Review GMP analytical data supporting product stability and release.
• Apply hands‑on knowledge of analytical techniques including HPLC, GC, chromatography, and spectroscopy.
• Support analytical method validation, verification, and transfer activities.
• Assess, implement, track, and close Change Controls.
• Support deviations, OOS/OOT investigations, root cause analysis, and CAPA activities.
• Utilize Veeva or other electronic QMS/document management systems.
• Perform analytical laboratory activities, including HPLC and analytical data review.
• Collaborate with CMOs/CTOs and cross‑functional teams.
• Apply knowledge of cGMP, ICH, USP, and applicable quality requirements.
• Biologics experience is a plus.

Skills

Change Control

Analytical testing

Data review

Quality systems

GMP

Investigations

CAPA

HPLC

GC

Chromatography

Spectroscopy

Education

Bachelor's degree or equivalent

Tools

Veeva

eQMS

Job description

Title: Analytical Quality & Change Control Specialist

Employment Type: Contract

Duration: 12+ Months

Status: Accepting Candidates

About the Role

We are seeking an experienced Analytical Quality & Change Control Specialist to support quality activities within a GMP-regulated environment. This role will focus on Change Control, analytical data review, investigations, CAPA, and quality systems, while partnering with analytical laboratories and cross-functional teams.

Key Responsibilities

• Manage and support Change Control activities within a GMP environment.
• Apply QC/QA experience with an emphasis on quality systems and Change Control.
• Review GMP analytical data supporting product stability and release.
• Apply hands‑on knowledge of analytical techniques including HPLC, GC, chromatography, and spectroscopy.
• Support analytical method validation, verification, and transfer activities.
• Assess, implement, track, and close Change Controls.
• Support deviations, OOS/OOT investigations, root cause analysis, and CAPA activities.
• Utilize Veeva or other electronic QMS/document management systems.
• Perform analytical laboratory activities, including HPLC and analytical data review.
• Collaborate with CMOs/CTOs and cross‑functional teams.
• Apply knowledge of cGMP, ICH, USP, and applicable quality requirements.
• Biologics experience is a plus.

Qualifications

• Bachelor's degree in a scientific or allied health field preferred; equivalent relevant experience may be considered.
• Strong experience with Change Control and analytical testing in a GMP environment.
• QC and/or QA experience with a focus on quality systems.
• Analytical laboratory experience with HPLC and data review.
• Experience supporting investigations, CAPA, and root cause analysis.
• Experience with Veeva or other eQMS/document management platforms.
• Experience working with CMOs/CTOs and cross‑functional teams.

Compensation

Estimated hourly range: $60–$65/hr W-2

Final rate within this range will be based on skills, experience, and interview results.