QA Investigations Specialist

About the role

In this pivotal role, you will be at the forefront of ensuring quality within the compounding pharmacy operations of both 503A and 503B facilities. Your primary responsibility will be to lead and support investigations into quality-related issues, collaborating closely with various quality teams. You will conduct comprehensive root cause analyses, document your findings, and work towards resolving deviations, nonconformances, and out-of-specification results, all while ensuring compliance with regulatory standards and internal protocols. You will serve as a key liaison between production, quality assurance, and regulatory affairs to drive corrective and preventive actions forward. This position demands a proactive mindset to identify trends and implement systemic improvements that prevent recurrence. You will be responsible for maintaining the integrity of the quality management system specific to sterile and non-sterile compounding environments. Success in this role will directly contribute to the company's mission of delivering safe, effective, and high-quality healthcare solutions.

Key facts

What you'll do

Investigate complex quality incidents within 503A and 503B compounding facilities to determine root causes and drive corrective actions.

Lead cross-functional investigation teams, coordinating with manufacturing, quality assurance, and regulatory affairs to ensure thorough and timely resolutions.

Perform detailed evaluations of batch records, equipment logs, and environmental monitoring data to identify deviations from established procedures.

Conduct systematic root cause analysis using structured methodologies to address deviations, nonconformances, and out-of-specification results.

Draft comprehensive investigation reports that clearly document findings, conclusions, and recommended corrective and preventive actions for quality systems.

Ensure all investigations comply with USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and current Good Manufacturing Practices (cGMP).

Collaborate with quality assurance to implement and track corrective and preventive actions (CAPA) to prevent recurrence and ensure regulatory compliance.

Utilize Google Workspace tools to manage documentation, communication, and data tracking throughout the investigation lifecycle.

Support the maintenance and continuous improvement of the company's quality management system and standard operating procedures.

Analyze investigation data to identify systemic issues and trends, recommending process improvements to enhance overall quality and compliance.

Serve as a subject matter expert during internal audits and regulatory inspections related to compounding quality systems and investigations.

Work closely with regulatory affairs to ensure timely responses to regulatory inquiries and audit preparations concerning quality investigations.

Provide training and guidance to site staff on investigation procedures, quality standards, and regulatory requirements for compounding operations.

Leverage quality systems software, when applicable, to streamline investigation workflows, data capture, and status tracking.

Demonstrate strong analytical and critical thinking skills to assess evidence, draw valid conclusions, and present findings effectively to stakeholders.

Requirements

A minimum of 3 years of experience in quality assurance, manufacturing, or a regulated industry; this can be substituted with relevant education.

In-depth knowledge of USP <795>, <797>, <800> standards, FDA 21 CFR Parts 210 & 211, and current Good Manufacturing Practices (cGMP).

Exceptional attention to detail, strong documentation skills, and excellent organizational capabilities.

Proven experience in managing investigations, handling deviations, and following escalation protocols.

Proficiency in using Google Workspace for documentation and communication.

Strong written and verbal communication skills, with an emphasis on interpersonal effectiveness.

A Pharmacy Technician or trainee license is preferred, or a willingness to obtain one.

Excellent technical writing abilities to produce clear and concise reports.

Strong teamwork skills, enabling effective collaboration with multidisciplinary teams.

Capability to juggle multiple investigations while adhering to tight deadlines.

Ability to maintain composure and professionalism when managing high-priority issues in a fast-paced environment.

Willingness to adhere to company policies and procedures related to quality, safety, and regulatory compliance.

Demonstrated ability to work independently with minimal supervision while maintaining accountability for deliverables.

Understanding of the importance of data integrity and confidentiality in handling sensitive quality information.

Commitment to upholding the highest standards of professionalism and ethical conduct in all quality-related activities.

Nice to have

Familiarity with quality systems software to enhance investigation processes.

Understanding of Good Distribution Practices (GDP) and Good Laboratory Practices (GLP).

Experience with electronic quality systems such as TrackWise or MasterControl is a plus.

Practical notes

The benefits package includes unlimited paid time off (PTO), company holidays, quarterly mental health days, and comprehensive health benefits encompassing medical, dental, and vision coverage. Additional perks include parental leave, participation in the Employee Stock Purchase Program (ESPP), and a 401k plan with employer matching. The company also organizes offsite team retreats to foster team bonding. Hims & Hers is committed to being an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.