GMP QA Specialist: Document Control & CAPA

Croda; Alabaster (AL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Excellent Medical, Dental, and Vision

PTO generously offered

401K Match

Wellness Reimbursement

Parental Leave

Career Development

Life and AD&D Insurance

Short- and long-term disability

Paid Holidays

Job summary

Croda is seeking a QA Specialist to maintain GMP document control, support batch releases, CAPA and investigations, and ensure adherence to FDA regulations. You will also contribute to training, vendor qualification, and internal audits within a cGMP framework.

The role involves data-driven quality improvement, annual product review, and collaboration with multiple teams to sustain high standards across manufacturing and quality systems in a site-based setting.

Qualifications

• Bachelor’s degree in natural sciences, engineering or management.
• 10–19 years’ experience in quality or operations in a cGMP environment.
• Pharmaceutical operations experience and FDA knowledge.
• CAPA/investigation oversight experience.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM specs and job descriptions.
• Conduct product releases/rejections via review of documents and results.
• Develop and deliver GMP training programs for employees.
• Implement CAPA to ensure timely closure of actions.
• Oversee qualification of facilities/equipment and IQ/OQ/DQ docs.
• Conduct Annual Product Review and QA input for shipments.
• Write and revise GMP docs and perform internal audits.
• Perform raw material qualification and vendor management.
• Assist during customer/FDA audits and manage deviations.
• Analyze quality metrics and report trends to management.

Skills

Document control

CAPA oversight

Data analysis

Quality systems

Regulatory awareness

Analytical thinking

Audits support

Education

Bachelor’s degree in natural sciences / engineering / management

Tools

MasterControl

MS Excel

Job description

Croda is seeking a QA Specialist to maintain GMP document control, support batch releases, CAPA and investigations, and ensure adherence to FDA regulations. You will also contribute to training, vendor qualification, and internal audits within a cGMP framework.

The role involves data-driven quality improvement, annual product review, and collaboration with multiple teams to sustain high standards across manufacturing and quality systems in a site-based setting.