Quality Assurance Investigations Specialist

Hims & Hers, New Albany, Ohio

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>.

What you need

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.

All jobs

Quality Assurance Investigations Specialist

Hims & Hers, New Albany, Ohio

The role

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

What you need

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.

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.

Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.

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.

To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement https://www.hims.com/global-candidate-privacy-statement.

Quality Assurance Investigations Specialist

The role

What you need

Education & Experience

Quality Assurance Investigations Specialist

The role

What you need

Education & Experience

Knowledge & Skills

QA Investigations Specialist

Event Investigation & Root Cause Analysis

Corrective and Preventive Actions (CAPA)

Compliance & Documentation

Cross-Functional Collaboration

Continuous Improvement

Key Competencies

There are more, but here are some highlights

Conditions of Employment

About Hims & Hers

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Hims & Hers