Lead QA Specialist: GMP, CAPA & Data-Driven Quality

United Pharma; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

MS Office skills

Job summary

United Pharma is seeking a Lead QA Specialist to manage document control and QA activities under GMP guidelines. You will oversee BPRs, SOPs, RM/AP specifications, and job descriptions, ensuring accuracy and timely updates.

The role requires strong data analysis, CAPA oversight, and collaboration with QA management to drive investigations, audits, and continuous improvement. Excellent communication and attention to detail are essential.

Qualifications

• Bachelor’s degree with 6+ years in QA/related field or an associate’s degree with 10+ years experience.
• Knowledge of cGMP and FDA regulations preferred.
• CAPA/investigation oversight experience preferred.
• Experience collecting, analyzing, and presenting quality data to management.
• Excellent written and verbal communication; strong attention to detail.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM, AP specs, and Job Descriptions.
• Review batch records and analytical results for product release decisions.
• Develop and deliver GMP training programs and services for staff.
• Lead CAPA processes to ensure timely closure and effectiveness.
• Assist in internal audits and participate in customer/FDA audits.
• Provide QA input for product shipments and labeling.
• Generate quality metrics using data systems and Excel pivots.
• Support calibration/maintenance data against quality standards.

Skills

Document control

CAPA oversight

Data analysis

GMP knowledge

Regulatory knowledge

Communication

Project leadership

Team collaboration

Multitasking

English proficiency

Education

Bachelor's degree

Associate's degree

Tools

MS Excel

MS Word

Outlook

MasterControl

Job description

United Pharma is seeking a Lead QA Specialist to manage document control and QA activities under GMP guidelines. You will oversee BPRs, SOPs, RM/AP specifications, and job descriptions, ensuring accuracy and timely updates.

The role requires strong data analysis, CAPA oversight, and collaboration with QA management to drive investigations, audits, and continuous improvement. Excellent communication and attention to detail are essential.