Laboratory Quality & Compliance Lead

Socket.dev; Columbus (OH); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Excellent full-time benefits

Medical, dental, vision

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Socket.dev is seeking a Laboratory Quality Specialist to maintain and improve the laboratory Quality Management System (QMS) to ensure regulatory compliance, data integrity, product quality, and patient safety in a regulated pharmaceutical lab environment.

This role supports the Laboratory Manager, oversees deviations, CAPA, change control, audits, supplier and equipment quality, COA release, and inspection readiness, requiring strong knowledge of cGMP, GLP, USP, and FDA practices.

Qualifications

• Bachelor’s degree in a scientific discipline required; advanced degree preferred.
• Minimum 4 years of QA/QC experience in a pharmaceutical or regulated lab.
• Experience supporting regulatory inspections, audits, CAPA, OOS/OOT, change control, training systems, and COA review/release.

Responsibilities

• Maintain and improve the laboratory QMS to align with cGMP/GLP and USP requirements.
• Review and approve quality policies, SOPs, forms, logs, and quality plans.
• Lead deviation investigations, CAPA, change control, and data integrity efforts.
• Support regulatory inspections, client audits, and internal audits.
• Prepare monthly/quarterly quality metrics and lead continuous improvement projects.

Skills

GxP knowledge

QMS improvement

Regulatory interpretation

Communication skills

Data integrity

Cross-functional collaboration

Education

Bachelor’s degree in Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, Medical Laboratory Science or related field

ASQ RAC ISO 9001/17025 Lean Six Sigma certs (preferred)

Tools

LIMS

EDMS (Electronic Document Management)

Job description

Socket.dev is seeking a Laboratory Quality Specialist to maintain and improve the laboratory Quality Management System (QMS) to ensure regulatory compliance, data integrity, product quality, and patient safety in a regulated pharmaceutical lab environment.

This role supports the Laboratory Manager, oversees deviations, CAPA, change control, audits, supplier and equipment quality, COA release, and inspection readiness, requiring strong knowledge of cGMP, GLP, USP, and FDA practices.