GMP QA Specialist — CAPA & Audits

Croda Singapore; Alabaster (AL); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Excellent Medical, Dental, and Vision

Wellness Reimbursement

Parental Leave

Life and AD&D Insurance

Short- and long-term disability

Job summary

Croda is seeking a QA Specialist to manage GMP document control, CAPA processes, and quality data for the Quality Assurance Division in Alabaster, AL. The role supports batch releases, training programs, audits, and continuous improvement across manufacturing operations.

The ideal candidate will hold a natural sciences/engineering degree with 10–19 years in quality roles, solid FDA knowledge, and experience with GMP systems and data analysis to drive product quality and compliance.

Qualifications

• Bachelor's degree in natural sciences, engineering, or management.
• 10–19 years in quality or operations in a cGMP environment.
• Pharmaceutical operations knowledge.
• Good knowledge of FDA regulations.
• CAPA/investigation oversight experience.
• Experience collecting, analyzing, and presenting data to management.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM specs, AP specs, and Job Descriptions.
• Conduct product releases/rejections including batch document reviews and specs comparisons.
• Develop and deliver GMP training programs for employees.
• Implement CAPA processes and ensure timely closure of actions.
• Oversee Facility/Equipment qualification and IQ/OQ/DQ documents.
• Conduct Annual Product Review.
• Assist during customer/FDA audits and supplier qualifications.
• Perform internal audits and review OOS documentation.
• Perform Change Control and validation program activities.

Skills

Quality Assurance

cGMP knowledge

Data analysis

CAPA investigations

Documentation control

Education

Bachelor's degree in natural sciences/engineering/related field

Tools

MasterControl

MS Excel

Job description

Croda is seeking a QA Specialist to manage GMP document control, CAPA processes, and quality data for the Quality Assurance Division in Alabaster, AL. The role supports batch releases, training programs, audits, and continuous improvement across manufacturing operations.

The ideal candidate will hold a natural sciences/engineering degree with 10–19 years in quality roles, solid FDA knowledge, and experience with GMP systems and data analysis to drive product quality and compliance.