Quality Assurance Investigations Specialist

QA Investigations Specialist

Quality Unit | New Albany, OH| Full-Time, On-Site

About the Role

We are seeking an experienced Quality Assurance Investigations Specialist to join the Quality Unit at our compounding pharmacy in New Albany, OH. In this role, you will lead and support investigations into quality-related events within our 503A compounding pharmacy operations. Reporting to the Quality Assurance Manager, you will partner closely with Quality Control (QC) and Quality Systems to ensure deviations, nonconformances, complaints, and other quality events are thoroughly investigated with rigorous root cause analysis and complete documentation.

You will ensure investigations are conducted in compliance with applicable regulatory requirements, including USP <795>, <797>, and <800>.

Key Responsibilities

Event Investigation & Root Cause Analysis

• Lead, document, and coordinate investigations of deviations, nonconformances, complaints, OOS results, and other quality events.
• Investigate customer complaints and quality-related events, working closely with pharmacists to assess product quality events
• Perform structured root cause analyses to determine true causes.
• Ensure timely initiation, progress, and closure of investigations within defined quality system timelines.
• Collaborate with production, the QC laboratory, and QA to gather evidence and assess event impact.

Corrective and Preventive Actions (CAPA)

• Identify and recommend appropriate CAPAs to prevent recurrence of issues.
• Ensure CAPA actions are practical, risk-based, and aligned with regulatory and company standards.
• Track CAPA implementation and verify effectiveness.

Compliance & Documentation

• Prepare clear, accurate, and compliant investigation reports in accordance with internal SOPs and regulatory requirements.
• Maintain complete records to support regulatory inspections and internal audits.
• Escalate critical issues to Quality leadership in a timely manner.

Cross-Functional Collaboration

• Work closely with QA, QC, and Quality Systems to ensure consistent application of investigation procedures.
• Facilitate communication between operations, technical teams, and quality groups during investigations.
• Participate in site-level quality review boards and investigation review committees.

Continuous Improvement

• Identify trends across investigations and recommend systemic improvements.
• Support training of staff on deviation reporting, investigation practices, and documentation standards.
• Contribute to the enhancement of site procedures for deviation and OOS management.

Education & Experience

• Bachelor's degree preferred in a relevant discipline (science, quality, or engineering-related field), or an equivalent combination of education and experience.
• 3+ years of related experience in quality, manufacturing, or a regulated industry may substitute for a degree.
• Pharmacy Technician or trainee license, or willingness to obtain one.

Knowledge & Skills

• Strong understanding of USP <795>, <797>, and <800> standards, FDA 21 CFR Parts 210 & 211, and cGMP; GDP and GLP experience preferred.
• Experience with investigations, deviation management, and escalation procedures.
• Excellent attention to detail, documentation practices, and organizational skills.
• Excellent written and verbal communication skills, including technical writing.
• Strong collaboration skills across multidisciplinary teams.
• Ability to manage multiple investigations under tight timelines.
• Proficiency in Google Workspace; proficiency with electronic quality systems (e.g., TrackWise, MasterControl) preferred.

Key Competencies

• Analytical and detail-oriented mindset.
• Strong problem-solving and decision-making abilities.
• Clear and professional communication.
• High sense of accountability and ownership.
• Ability to work independently and within cross-functional teams.

Our Benefits

There are more, but here are some highlights

• Competitive salary & equity compensation for full-time roles
• Unlimited PTO, company holidays, and quarterly mental health days
• Comprehensive health benefits, including medical, dental & vision, and parental leave
• Employee Stock Purchase Program (ESPP)
• 401(k) with employer matching contribution
• Offsite team retreats

Conditions of Employment

• This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of working with these drugs. These items would include gloves, respiratory protection, gown and other items as required.
• This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
• Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time and lifting up to 80% of the time for up to a twelve hour shift. Must be able to lift up to 50lbs.
• Due to the risk of reproductive capability in handling or compounding certain Hazardous Drugs (HD) associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity and reproductive effects) of handling hazardous drugs.

We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply-even if you're not sure if your background or experience is a perfect match.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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