Quality Assurance Specialist — Risk & CAPA

Express Employment Professionals - Cincinnati East; Birmingham (AL); On-site; USD 28,000 - 33,000; Full time

Job summary

Express Employment Professionals - Cincinnati East in Birmingham, AL seeks a Quality Assurance professional to perform QA activities focused on risk management, report writing, and deviation handling. The role reports to the Director of Quality and supports time-sensitive projects.

The ideal candidate holds a science/engineering degree with 3+ years in an FDA-regulated QA role, knowledge of cGMP, CAPA, and QC tools, plus strong written and verbal communication and meticulous attention to detail.

Qualifications

• Bachelor’s degree in a scientific discipline or engineering is strongly preferred.
• At least three years of practical experience in a Quality role in an FDA-regulated company.
• Experience working to cGMP guidelines and familiarity with quality concepts, practices and procedures.
• Preferred: ASQ or Six Sigma certification.
• Experience working with Production or Manufacturing.
• Excellent verbal and written communication skills.
• Excellent attention to detail.
• Proficient with data entry, Microsoft Office, Adobe, inventory management software, and eQMS.
• Able to work as part of a small team in a fast-paced environment.
• Strong time management and ability to work independently.

Responsibilities

• Conducts risk assessment and root cause analysis using quality tools (FMEA, gap analysis).
• Familiar with regulatory guidance as it applies to FDA-regulated manufacturing facilities.
• Assists with studies to inspect, test, and evaluate the reliability of processes, products and equipment.
• Performs trending on key metrics to support Product Annual Review and Quality Management Review.
• Supports the CAPA program and completes corrective and preventative actions in a timely manner.
• Conducts CAPA effectiveness checks and documents results.
• Attends required meetings and communicates clearly, verbally and in writing.
• Writes deviations as needed.

Skills

Technical writing

Attention to detail

Verbal communication

Written communication

Time management

Teamwork

Independent work

Education

Bachelor’s degree in scientific discipline/engineering

Tools

Adobe

Microsoft Office

Inventory management software

eQMS

Job description

Express Employment Professionals - Cincinnati East in Birmingham, AL seeks a Quality Assurance professional to perform QA activities focused on risk management, report writing, and deviation handling. The role reports to the Director of Quality and supports time-sensitive projects.

The ideal candidate holds a science/engineering degree with 3+ years in an FDA-regulated QA role, knowledge of cGMP, CAPA, and QC tools, plus strong written and verbal communication and meticulous attention to detail.