Quality Assurance Support

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

Job Summary:

This position is responsible for performing Quality Assurance activities with a focus on risk management, report writing, and deviation handling. The critical skills for this role are demonstrable technical writing abilities and a drive towards continuous improvement. The position will support in carrying out time sensitive projects. This position reports directly to the Director of Quality.

Here’s What Your Day-to-Day Looks Like:

Essential Duties and Responsibilities

• Conducts risk assessment and root cause analysis using Quality tools (FMEA, gap analysis, etc.)
• Familiar with regulatory guidance and proposed changes as they apply to 503b manufacturing facilities.
• Assists with studies to inspect, test, and evaluate the reliability of manufacturing processes, products, and equipment.
• Performs trending on key metrics to support Product Annual Review and Quality Management Review.
• Supports the CAPA program. Works cross-functionally to complete Corrective and Preventative Actions (CAPAs) in a timely manner.
• Conducts CAPA effectiveness checks and documents results.
• Attends all required meetings and provides clear, professional verbal and email communication.
• Performs other duties, such as writing deviations, as

Skills and Experience Required

• Bachelor’s degree in scientific discipline/engineering strongly preferred.
• At least three years(preferred) of practical experience of in a Quality role in an FDA regulated company.
• Experience working to cGMP guidelines and demonstrated expertise in variety of the field’s concepts, practices, and procedures.
• Preferred: Continuing education such as ASQ or Six Sigma certification.
• Experience working with Production or Manufacturing.
• Must exhibit excellent verbal and written communication skills.
• Must exhibit excellent attention to detail.
• Exceptional computer skills (data entry, Microsoft Office products, Adobe, inventory management software, eQMS).
• Ability to work as part of a small team in a fast-paced environment.
• Possess time management skills and the ability to work independently, multitask, complete projects according to deadlines.

Additional Notes

• Must be willing and able to gown for ISO 8 area.

Schedule & Pay:

• FULL TIME; Mon-Fri, 8:00am-5:00pm
• Willingness to work overtime if needed, including weekends
• $20-24/hr

Here’s What Makes YOU a Great Fit:

• Able tophysically do the work and meet physical requirements (willing to work outside in the elements, get dirty, deal with smells, etc.)
• Must have reliable and timely transportation
• Good work ethic; punctual & dependable; take pride in your work
• Good teamwork and communication skills
• Steel toed boots recommended but not required
• Drug-free; background check

Job Location: Birmingham, AL