Laboratory Quality & Compliance Lead

STAQ Pharma; Columbus (OH); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

STAQ Pharma is seeking a Laboratory Quality Specialist to maintain and improve the laboratory QMS to support regulatory compliance, data integrity, product quality, laboratory impartiality, and patient safety within a regulated pharmaceutical environment.

This role works with the Laboratory Manager to coordinate quality system activities, drive continuous improvement, manage deviations and CAPA, and ensure adherence to cGMP, GLP, USP, and FDA requirements.

Qualifications

• Bachelor’s degree in life sciences required; advanced degree preferred.
• Minimum 4 years QA/QC experience in a regulated laboratory environment.
• Experience supporting regulatory inspections and client/internal audits.

Responsibilities

• Maintain and improve the laboratory QMS for cGMP/GLP compliance.
• Review and approve quality policies, SOPs, forms, logs, and work instructions.
• Lead deviation investigations, CAPA, OOS/OOT investigations, and change control.
• Support regulatory inspections and client/internal audits.
• Track quality metrics and drive continuous improvement.
• Ensure data integrity and laboratory impartiality.

Skills

GxP knowledge

QMS management

CAPA

Data integrity

Regulatory communication

Audit coordination

Education

Bachelor’s degree in life sciences

Tools

LIMS

Excel

EDMS

Job description

STAQ Pharma is seeking a Laboratory Quality Specialist to maintain and improve the laboratory QMS to support regulatory compliance, data integrity, product quality, laboratory impartiality, and patient safety within a regulated pharmaceutical environment.

This role works with the Laboratory Manager to coordinate quality system activities, drive continuous improvement, manage deviations and CAPA, and ensure adherence to cGMP, GLP, USP, and FDA requirements.