GMP Quality Specialist

Job Description

Job Description

About Tobin Scientific

Tobin Scientific is a leading provider of cold chain, ambient storage, and transport & logistics services for the biopharma industry. We proudly support a diverse clientele spanning life sciences, academia, government, and more. Recognized for unwavering safety and reliability in the storage and transport of temperature-sensitive products, we excel in serving the complex needs of the pharmaceutical and biotech sectors. Our capabilities extend to laboratory relocation, principal investigator support, and other logistic services. Tobin Scientific's all-encompassing approach and commitment to quality make us an industry innovator, empowering our partners through the complexities of the biopharma industry.

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:
The annual salary range for this position is as follows:

$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.