Senior QA Specialist, GMP & Regulatory Compliance

Croda Singapore; Alabaster (AL); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

Wellness Reimbursement

Parental Leave

Life Insurance

Job summary

Croda is seeking a QA Specialist at our Alabaster, AL site to support GMP document control and quality assurance activities. You will manage BPRs, SOPs, RM/AP specs, and ensure timely release of materials and finished products.

Responsibilities include CAPA oversight, data analysis, annual product review, and collaboration with quality, regulatory, and operations teams to drive continuous improvement. This role requires a strong GMP background and effective communication.

Qualifications

• Bachelor’s Degree required in the field of natural sciences, engineer or management preferred.
• Minimum of 10-19 years’ experience in quality or operations, primarily in a cGMP environment.
• Pharmaceutical operations experience and/or knowledge required.
• Good knowledge of FDA regulations.
• Prior CAPA / Investigation oversight experience preferred.
• Experience in collecting, analyzing, and presenting data and recommendations to management.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM specs and AP specs.
• Conduct product releases/rejections including review of batch documents and results.
• Develop and deliver training programs on GMP and product knowledge.
• Implement CAPA processes to ensure timely closure.
• Oversee qualification documents and IQ/OQ/DQ reviews.
• Perform Annual Product Review and QA input for shipments.
• Write and revise BPRs, SOPs, specs and Job Descriptions.
• Perform internal audits and vendor qualification.

Skills

Quality Assurance

Regulatory compliance

CAPA oversight

Data analysis

Documentation control

Education

Bachelor's Degree in natural sciences, engineering or management

Tools

MS Excel

MasterControl

Job description

Croda is seeking a QA Specialist at our Alabaster, AL site to support GMP document control and quality assurance activities. You will manage BPRs, SOPs, RM/AP specs, and ensure timely release of materials and finished products.

Responsibilities include CAPA oversight, data analysis, annual product review, and collaboration with quality, regulatory, and operations teams to drive continuous improvement. This role requires a strong GMP background and effective communication.