Senior In-Process Quality Engineer — cGMP & CAPA Expert

Paladin Labs Inc.; New York, Northern (NY, KY); Hybrid; USD 100,000 - 135,000; Full time

Job summary

Par Health is seeking a Quality Assurance subject matter expert to oversee cGMP compliance across quality systems and product lines. This role includes SOP approval, CAPA and Change Control leadership, investigations, and risk assessment to ensure quality products and regulatory readiness.

You will guide process improvements, trend quality metrics, support regulatory submissions, and participate in audits and internal improvements across manufacturing operations.

Qualifications

• Bachelor degree in engineering or related pharmaceutical manufacturing field preferred; or an Associate degree with equivalent experience.
• Minimum of 5 years of technical experience in a pharmaceutical manufacturing environment (QA/QC or engineering).
• Base pay range noted for this position is $100,000 – $135,000.

Responsibilities

• Evaluates, updates, and approves existing SOPs for cGMP compliance and alignment with corporate procedures.
• Oversees Change Control, CAPA processes, and writes/approves related documentation.
• Leads Process Improvement and conducts Quality System trending (Exceptions, CAPA, Change Control, ARP, audits).
• Supports Investigations, root cause analyses, and determines product impact and disposition.
• Assists in compilation of eCTD NDA/ANDA documentation and regulatory strategy requests.
• Participates in product/process development and transfer teams and supports internal/external audits.

Skills

Quality Systems

cGMP

CAPA

Change Control

Root Cause Analysis

Regulatory Compliance

Education

Bachelor degree in engineering or related pharmaceutical field

Associate degree with equivalent experience

Tools

EQMS

Minitab

MS Office

Job description

Par Health is seeking a Quality Assurance subject matter expert to oversee cGMP compliance across quality systems and product lines. This role includes SOP approval, CAPA and Change Control leadership, investigations, and risk assessment to ensure quality products and regulatory readiness.

You will guide process improvements, trend quality metrics, support regulatory submissions, and participate in audits and internal improvements across manufacturing operations.