About the Role

We are seeking a detail-oriented and reliable Quality Specialist II 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.

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 3 years 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:

• Bachelors/Masters degree in a relevant discipline
• 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

$70,000-90,000