Senior QA Lead — GMP, CAPA & Documentation

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

Benefits offered by this job

Health benefits

PTO

401K Match

Wellness Reimbursement

Parental Leave

Career development

Life Insurance

Disability

Paid holidays

Job summary

Croda is seeking a Lead QA Specialist in Alabaster, AL to maintain GMP documents, review data, and escalate quality events. The role focuses on BPR/SOP control, batch review, and CAPA oversight, within a site-based QA team.

The candidate should have a Bachelor’s with 6+ years (or an Associate with 10+ years) in a related field, plus cGMP/FDA knowledge and strong data analysis. This role offers growth, comprehensive benefits, and a collaborative environment.

Qualifications

• Bachelor’s Degree with a minimum of 6 years of experience in an applicable field or Associate’s degree with a minimum of 10 years of experience in an applicable field.
• Knowledge of cGMP preferred.
• Knowledge of FDA regulations preferred.
• Prior CAPA / Investigation oversight experience preferred.
• Experience in collecting, analyzing, and presenting data and recommendations to management.
• Effective written and verbal communication skills required.
• Proficient in Word, Excel, Outlook.
• High attention to detail.
• Good command of the English language.
• Intermediate math skills.
• Excellent organizational ability.
• Work collaboratively with others.
• Ability to manage and lead projects assigned by QA Management.
• Able to manage multiple priorities and follow through on projects to completion.

Responsibilities

• Perform Document Control for BPRs, SOPs, RM specs and AP specs.
• Conduct product releases/rejections including review of batch documentation.
• Design and deliver high quality training programs on GMP knowledge.
• Implement CAPA processes and ensure timely closure.
• Oversee qualification and IQ/OQ/DQ documents.
• Conduct Annual Product Review.
• Provide QA input for shipments including labels and packaging.
• Write and revise BPRs, SOPs, specs and job descriptions.
• Perform internal audits and raw material qualification.
• Prepare for customer/FDA audits.
• Review/Approve OOS documentation.
• Perform Change Control activities.
• Support validation programs.
• Maintain calibration/maintenance databases for equipment.
• Keep training current per Quality Management tools.
• Follow all policies from Management/Regulatory Affairs.

Skills

Quality Assurance

cGMP knowledge

FDA regulations

CAPA oversight

Data analysis

Communication

Microsoft Word/Excel

Team leadership

Education

Bachelor's in Science

Associate degree +10 yrs exp

Tools

MasterControl

Excel

Word

Outlook

Job description

Croda is seeking a Lead QA Specialist in Alabaster, AL to maintain GMP documents, review data, and escalate quality events. The role focuses on BPR/SOP control, batch review, and CAPA oversight, within a site-based QA team.

The candidate should have a Bachelor’s with 6+ years (or an Associate with 10+ years) in a related field, plus cGMP/FDA knowledge and strong data analysis. This role offers growth, comprehensive benefits, and a collaborative environment.