Quality Specialist 1

Lead Candidate; Boston; On-site; USD 65,000 - 78,000; Full time

Job summary

A leading company in therapeutic innovation seeks a Quality Specialist 1 for an entry-level role in maintaining standards and compliance in a GMP environment. Ideal candidates should have experience in regulated environments and a strong attention to detail. Responsibilities include documentation review, cross-department collaboration, and supporting quality assurance processes.

Qualifications

• At least 1 year of experience in a pharmaceutical, biotech, food, or regulated manufacturing environment.
• Certification in quality systems, GMP, or related area preferred.

Responsibilities

• Support documentation review and ensure compliance with Good Manufacturing Practices.
• Collaborate with various departments to resolve quality issues.
• Participate in internal audits and support external regulatory inspections.

Skills

Attention to detail

Communication skills

Education

High school diploma or GED

Completion of a technical or vocational program in life sciences

Tools

Microsoft Office

Job description

About the Company

At the heart of therapeutic innovation, this organization provides flexible GMP cleanroom suites and operational support for life sciences companies focused on clinical or commercial production. Facilities include ISO 7/8-classified cleanrooms, secure IT infrastructure, and dedicated office and meeting space. Spaces are tailored to individual process and equipment needs, with services such as material and inventory management, routine cleaning, waste handling, and onsite support. The goal is to offer a reliable, compliant environment that helps teams stay focused, organized, and ready to advance their work.

About the Role

We are seeking a detail-oriented and reliable Quality Specialist 1 to support our clients in the life sciences. This entry-level position plays a key role in maintaining quality standards, supporting documentation review, and ensuring compliance with Good Manufacturing Practices (cGMP) and company procedures. Ideal for individuals with hands-on experience in regulated environments, strong documentation skills, or quality-related certifications.

This is a full on-site position between 2 different sites both in Boston.

Responsibilities

• Collaborate cross-functionally with Operations, Testing Services, and other departments to resolve quality issues.
• Support deviation, CAPA, and change control processes.
• Participate in internal audits, inspection readiness activities, and support external regulatory inspections as needed.
• Assist in reviewing and maintaining controlled documents (SOPs, incoming material lot files, logbooks, forms).
• Perform data entry and record review in quality systems (paper-based or electronic).
• Conduct room and equipment release under supervision.
• Assist in reviewing validation protocols for completeness and accuracy.
• Maintain accurate and up-to-date training records.
• Follow Good Documentation Practices (GDP) and contribute to a culture of compliance and continuous improvement.

Requirements

Essential:

• High school diploma or GED
• At least 1 year of experience in a pharmaceutical, biotech, food, or regulated manufacturing environment
• Completion of a technical or vocational program in life sciences, chemistry, biotechnology, or manufacturing

Preferred:

• Certification in quality systems, GMP, or related area (e.g., ASQ Certified Quality Technician)
• Familiarity with FDA regulations, cGMP, or ISO quality systems
• Experience handling quality documentation and reports
• Strong attention to detail and communication skills
• Proficiency in Microsoft Office (Word, Excel)

Compensation range

$65,000-78,000