QA Analyst (non-technical)

POSITION TITLE: Quality Assurance Analyst

REPORTING TO: Senior Quality Assurance Specialist

POSITION TYPE & LOCATION: Full-time, Exempt position based in Birmingham, AL

Position and Scope

This position is responsible for performing Quality Assurance activities with a focus on complaint, nonconformance, and deviation handling. The critical skills for this role are demonstrable technical writing abilities and a drive towards continuous improvement. The Quality Assurance Analyst will support Asteria Health in carrying out the mission of the company. This position reports directly to the Senior Quality Assurance Specialist.

Essential Duties and Responsibilities

· Logs, trends, and documents Deviations, Nonconformances, and customer complaints.

· Ensures quality events are escalated and effectively communicated across departments.

· 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 and present to Senior Leadership Team.

· 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.

· Executes change controls and develops training to support corrective actions as required.

· Attends all required meetings and provides clear, professional verbal and email communication.

· Performs other duties as assigned.

Skills and Experience Required

· Bachelor’s degree in scientific discipline/engineering (required).

· At least three years of practical experience in a Quality role in an FDA regulated company. (required)

· Experience working on cGMP guidelines and demonstrated expertise in a variety of the field’s concepts, practices, and procedures. (required)

· 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.

Job Type: Full-time

Pay: $65,000.00 - $70,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Compensation Package:

• Yearly pay

Schedule:

• 8 hour shift

Work Location: In person

Salary : $65,000 - $70,000