СШАIncoming Quality Control (IQC) Supervisor
1 нед. назад
СШАSeniorOnsite
quality assuranceusp <795>usp <797>usp <800>
Supervise incoming raw material quality control in a pharmaceutical compounding facility ensuring compliance with USP standards.
Обязанности
- At Hims & Hers, we are committed to advancing patient safety by producing high-quality, sterile compounded medications. As the Incoming QC Supervisor, you will play a vital role in ensuring material quality and supporting a culture of compliance, excellence, and continuous improvement.
- The Incoming Quality Control (QC) Supervisor oversees the quality assurance activities related to incoming raw materials, components, and supplies within a 503A facility. This role ensures compliance with USP <795>, <797>, and <800>, as well as internal quality standards. The Incoming QC Supervisor leads the review, approval, and disposition processes for materials, manages a team of quality staff, and partners with cross-functional departments to maintain a robust quality system that supports patient safety and product integrity.
Требования
- Education & Experience:
- Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biology, or related field required.
- Minimum 3–5 years of QA/QC experience in a 503A, 503B or cGMP-regulated environment; experience in sterile compounding or pharmaceutical manufacturing preferred.
- At least 1–2 years of supervisory or team leadership experience is strongly preferred.
- Knowledge & Skills:
- Strong understanding of cGMP, USP <795>, <797>, <800> and other applicable regulatory requirements.
- Knowledge of raw material testing, supplier quality, and risk-based quality management.
- Excellent communication, leadership, and problem-solving skills.
- Strong organizational skills with attention to detail and ability to manage multiple priorities.
- Proficiency in quality management systems (QMS), electronic documentation systems, Google and Microsoft Office Suite.
- Ability to stand, sit, and walk for extended periods in an office, laboratory, or cleanroom environment.
- May require gowning and working within controlled cleanroom areas.
- Occasional lifting of up to 25 lbs.
Условия
- 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)
- 401k benefits with employer matching contribution
- 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 .
Другое
- Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
- Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.
- Supervise and mentor IQC personnel responsible for incoming material inspections, documentation review, and disposition.
- Schedule and prioritize IQC activities to align with production and supply chain needs.
- Provide training, coaching, and performance feedback to ensure staff competency and regulatory compliance.
- Oversee the review and approval of Certificates of Analysis (CoA), Certificates of Conformance (CoC), and vendor documentation.
- Ensure all incoming raw materials, components, and supplies meet established specifications prior to release for use in compounding operations.
- Maintain accurate records of inspection, testing, and disposition in compliance with data integrity standards.
- Ensure IQC activities comply with USP ,795>, <797>, <800>, and other regulatory documents, where applicable..
- Manage deviations, nonconformances, and out-of-specification (OOS) results related to incoming materials.
- Support supplier qualification, auditing, and vendor performance monitoring programs.
- Participate in internal and external audits, inspections, and regulatory agency interactions as needed.
- Identify and implement process improvements to enhance efficiency, compliance, and reliability of incoming QC operations.
- Conduct risk assessments related to supplier and material quality.
- Collaborate with Procurement, Quality Control, and Compounding teams to address and resolve quality issues.