Laboratory Quality & Compliance Specialist

ADP, Inc.; Columbus (OH); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Comprehensive medical coverage

Dental and vision options

Job summary

ADP, Inc. seeks a Laboratory Quality Specialist to maintain and improve the Quality Management System in a regulated pharmaceutical lab environment. You will oversee QMS governance, data integrity, and assay defensibility while supporting inspections and supplier quality activities.

The role requires strong knowledge of cGMP, GLP, USP expectations, and cross-functional collaboration to ensure impartiality from manufacturing operations and ongoing quality improvements.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Biochemistry, Microbiology, Pharmaceutical Sciences, or related field.
• Minimum 4 years of QA/QC in a pharmaceutical or regulated laboratory environment.
• Experience supporting regulatory inspections, client audits, internal audits, deviation investigations, CAPA, OOS/OOT investigations, change control, training systems, analytical report and COA review/release.
• ASQ, RAC, ISO 9001, ISO 17025, Lean Six Sigma or related quality/regulatory certification preferred but not required.

Responsibilities

• Quality Management System Support & Governance: maintain and improve the laboratory QMS to align with cGMP, GLP, USP and regulatory expectations.
• Review and approve lab quality policies, SOPs, forms, logs, quality plans and work instructions.
• Perform deviation investigations, CAPA, OOS/OOT investigations, change control, and COA review/release.
• Support regulatory inspections, client audits and internal audits.
• Lead or participate in continuous improvement projects for compliance and efficiency.

Skills

GxP knowledge

QMS management

Regulatory communication

Data integrity

Root cause analysis

Technical writing

Microsoft Office

LIMS experience

Education

Bachelor's degree in Chemistry/Biology/Biochemistry/Microbiology/Pharmaceutical Sciences

Advanced degree preferred

Tools

LIMS

Electronic document management systems

Data trending tools

Job description

ADP, Inc. seeks a Laboratory Quality Specialist to maintain and improve the Quality Management System in a regulated pharmaceutical lab environment. You will oversee QMS governance, data integrity, and assay defensibility while supporting inspections and supplier quality activities.

The role requires strong knowledge of cGMP, GLP, USP expectations, and cross-functional collaboration to ensure impartiality from manufacturing operations and ongoing quality improvements.