GMP Quality Specialist

Tobin Scientific; Methuen (MA); On-site; USD 90,000 - 110,000; Full time

Job summary

A leading scientific company is seeking a GMP Quality Specialist in Methuen to ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Responsibilities include quality checks, documentation review, and collaboration with teams. The ideal candidate has a Bachelor’s degree in Life Sciences and 2-3 years of experience in GMP environments. Competitive pay range is $90,000 to $110,000 annually, with opportunities for professional growth.

Qualifications

• 2-3 years of experience in a GMP Quality role within a relevant environment.
• Strong understanding of GMP principles and documentation compliance.
• Excellent organizational and communication skills.

Responsibilities

• Perform data entry and record management for GMP operations.
• Conduct quality checks and ensure compliance with GMP and GDP.
• Collaborate with teams to maintain quality standards.

Skills

Attention to detail

Collaboration

Quality Management Systems

Data integrity

Education

Bachelor's degree in Life Sciences or related technical discipline

Tools

Microsoft Office Suite

eQMS or ERP platforms

Job description

This range is provided by Tobin Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base Pay Range

$90,000.00/yr - $110,000.00/yr

Position Summary

The GMP Quality Specialist is responsible for providing day-to-day quality support for GMP warehousing and fleet operations. This role focuses on ensuring compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) through quality data entry, material checks, and execution of quality system activities. The Quality Specialist will support operational excellence by maintaining high standards of documentation, data integrity, and compliance within the Quality Management System (QMS).

Location

Methuen (with up to 10% travel to New Jersey site)

Key Responsibilities

• Perform data entry and record management in support of GMP warehousing and labeling activities.
• Conduct quality checks of materials prior to shipment to ensure compliance with GMP and GDP requirements.
• Verify and review documentation for accuracy, completeness, and adherence to approved procedures.
• Support the implementation and maintenance of site quality systems, including:
• Deviations – assist with documentation, tracking, and closure.
• CAPAs – support investigation summaries and effectiveness checks.
• Change Controls – assist in documentation and coordination of changes impacting materials or processes.
• Training – ensure training compliance and record accuracy for site personnel.
• Participate in routine warehouse walk-throughs to ensure compliance with GMP, GDP, and safety requirements.
• Maintain accurate, timely, and compliant records within electronic systems (e.g., QMS, WMS, etc.).
• Collaborate with cross-functional teams, including Operations and Facilities to ensure quality standards are met.
• Assist with the review and approval of controlled documents such as SOPs, logs, and forms.
• Promote a culture of continuous improvement and compliance across the site.
• Travel up to 10% of the time to the company's New Jersey GMP warehouse to support quality system implementation.

Education

• Bachelor's degree in Life Sciences (e.g., Biology, Chemistry, Biochemistry), Engineering, or related technical discipline required.

Experience and Qualifications

• 2-3 years of experience in a GMP Quality role (e.g., Quality Assurance, Quality Control, or Quality Operations) within a pharmaceutical, biotechnology, or medical device environment.
• Strong understanding of GMP principles, including documentation, recordkeeping, and data integrity.
• Experience supporting warehouse and fleet operations under GMP conditions preferred.
• Working knowledge of Quality Management Systems (QMS) and quality processes (deviations, CAPA, change control).
• Excellent attention to detail and accuracy in documentation and data entry.
• Proficiency with Microsoft Office Suite and familiarity with electronic systems such as eQMS or ERP platforms.
• Strong organizational and communication skills with the ability to work collaboratively across departments.
• Self‑motivated, reliable, and able to prioritize tasks in a fast‑paced, compliance‑driven environment.

Pay Range: $90,000 - $110,000.

Compensation depends on relevant experience and/or education, specific skills, function, geographic location, and other factors as applicable by law.

Tobin Scientific is an equal opportunity employer and values diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. We are committed to creating an inclusive environment for all our employees.