QA Lead - GMP, CAPA & Document Control

Croda Singapore; Alabaster (AL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Wellness Reimbursement

Parental Leave

Life Insurance

Disability Insurance

Job summary

Croda, a global life sciences company based in Alabama, is seeking a Lead QA Specialist to own document control for GMP and QA activities at the Alabaster site. You will manage batch records, SOPs, CAPA investigations, data analysis and prepare for customer and FDA audits, collaborating across QA, manufacturing and quality systems.

The role requires knowledge of cGMP and FDA regulations, strong communication, project leadership, and attention to detail to ensure compliance and continuous

Qualifications

• Bachelor’s degree with ≥6 years in QA or associate degree with ≥10 years.
• Knowledge of cGMP and FDA regulations preferred.
• Strong data analysis and presentation skills; high attention to detail.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM specs, AP specs and Job Descriptions.
• Conduct product releases/rejections including review of batch docs and analyses against specs.
• May design and deliver high quality training programs providing GMP/product knowledge.
• Implement CAPA process and ensure timely closure of CAPAs.
• Oversee Facility/Equipment qualification and IQ/OQ/DQ documents.
• Provide QA input for product shipments and release, labeling, and paperwork.
• Write and revise quality documents on a timely basis.
• Perform annual document reviews and internal audits.
• Conduct raw material qualification and vendor management.
• Assist during customer/FDA audits and Change Control processes.
• Perform process/method validation and calibration maintenance.

Skills

Document control

Data analysis

Quality systems

GMP knowledge

Communication skills

Project management

Team collaboration

Excel

Education

Bachelor’s Degree in a relevant field

Associate's degree with 10+ years experience

Tools

Word

Excel

Outlook

MasterControl

Job description

Croda, a global life sciences company based in Alabama, is seeking a Lead QA Specialist to own document control for GMP and QA activities at the Alabaster site. You will manage batch records, SOPs, CAPA investigations, data analysis and prepare for customer and FDA audits, collaborating across QA, manufacturing and quality systems.

The role requires knowledge of cGMP and FDA regulations, strong communication, project leadership, and attention to detail to ensure compliance and continuous