Quality Investigations Coordinator — CAPA & Compliance

Empower Pharmacy; Georgia; On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) matching

Paid time off

Wellness perks

IV therapy

Job summary

Empower Pharmacy is a mission-driven healthcare company advancing patient care through a robust quality program. The QO Investigations Coordinator will support product integrity and compliant quality operations by coordinating investigations, maintaining records, and advancing timely resolutions within our regulated 503A/503B environments.

The role emphasizes data collection, root-cause support, CAPA tracking, documentation accuracy, and collaboration with cross-functional partners to drive

Qualifications

• Minimum of two years of Quality Assurance or Quality Control experience within a pharmaceutical or healthcare environment, including investigation or documentation exposure.
• Associate degree in a scientific or technical discipline, or an equivalent combination of education and regulated manufacturing or health science experience.
• Demonstrated ability to collect, analyze, and document quality data accurately while following established procedures and supporting investigation timelines.
• Strong written communication, attention to detail, organization, and cross-functional coordination skills in a regulated, documentation-driven work environment.
• Experience supporting deviations, non-conformances, CAPAs, trending reports, or investigation tracking within pharmaceutical manufacturing or another regulated quality setting preferred.
• Certified Quality Improvement Associate (CQIA) preferred.

Responsibilities

• Data Collection: Collect and organize investigation data for deviations, non-conformances, and laboratory or production events to support accurate, evidence-based assessments.
• Initial Assessment: Conduct initial event assessments using approved templates and guidance, documenting relevant facts, observations, and potential contributing factors clearly.
• Investigation Writing: Draft investigation documentation that accurately summarizes evidence, analysis, conclusions, and follow-up requirements in accordance with established procedures.
• CAPA Tracking: Track corrective and preventive action commitments, due dates, and follow-up activities to support timely, complete implementation across responsible functions.
• Record Maintenance: Maintain complete investigation records and supporting documentation, ensuring information remains organized, traceable, current, and aligned with procedural requirements.
• Compliance Support: Apply cGMP and applicable USP <795>, USP <797>, and USP <800> requirements when documenting investigations and coordinating quality follow-up activities.
• Team Coordination: Collaborate with Quality leadership and cross-functional partners to gather information, resolve documentation gaps, and advance investigations toward timely closure.
• Trend Reporting: Compile investigation metrics and trending reports that identify recurring issues, emerging patterns, and practical opportunities for continuous improvement.
• Issue Escalation: Escalate missing information, overdue actions, or investigation barriers promptly, enabling Quality leadership to address risks and maintain execution discipline.

Skills

Quality investigations

cGMP

USP standards

CAPA

Data analysis

Documentation

Education

Associate degree in science

Tools

Excel

Word

Investigation tracking systems

Job description

Empower Pharmacy is a mission-driven healthcare company advancing patient care through a robust quality program. The QO Investigations Coordinator will support product integrity and compliant quality operations by coordinating investigations, maintaining records, and advancing timely resolutions within our regulated 503A/503B environments.

The role emphasizes data collection, root-cause support, CAPA tracking, documentation accuracy, and collaboration with cross-functional partners to drive