Quality Specialist, Peptide API & Development

About the role

Hims & Hers is seeking a Quality Specialist to manage quality operations at a peptide API development and manufacturing facility. This position focuses on building a compliant, inspection-ready foundation for early-phase drug product development and future tech transfers.

Key facts

What you'll do

• Manage daily quality system tasks including document control, training, deviations, CAPA, and change control.
• Verify GMP records for accuracy and adherence to Good Documentation Practices.
• Handle the issuance, tracking, and archival of SOPs, logbooks, and technical reports.
• Review batch records for peptide API production and escalate discrepancies to leadership.
• Monitor and coordinate the lifecycle of investigations and corrective actions.
• Oversee training matrices and ensure staff completion of required modules.
• Conduct facility walkthroughs in manufacturing and laboratory areas to ensure compliance.
• Assist with qualification and validation documentation during site startup.
• Oversee incoming material specifications and supplier quality records.
• Prepare documentation for internal and external audits to ensure inspection readiness.
• Track quality metrics to support management reviews and process improvements.
• Collaborate with engineering and operations teams to integrate quality standards into workflows.

Requirements

• Bachelor degree in Chemistry, Biology, Biochemistry, Pharmaceutical Sciences, or a related field.
• 2 to 5+ years of experience in quality, manufacturing, or document control within a GMP-regulated industry.
• Working knowledge of cGMP principles and Good Documentation Practices.
• Ability to manage multiple priorities in a startup environment.
• Capability to work onsite in manufacturing and laboratory settings.

Nice to have

• Experience with peptide API production or sterile operations.
• Background in laboratory controls or site startup environments.
• Proficiency with electronic quality, document management, or training systems.

Skills & tools

• GMP Quality Systems
• Document Control
• CAPA and Deviation Management
• Batch Record Review
• Electronic Quality Management Systems (eQMS)

Practical notes

• Benefits include unlimited PTO, quarterly mental health days, medical/dental/vision coverage, parental leave, 401k matching, and an Employee Stock Purchase Program.
• The role requires regular onsite presence and potential flexibility in hours to support operational startup needs.
• Hims & Hers provides reasonable accommodations for individuals with disabilities; requests can be directed to accommodations@forhims.com.
• The company adheres to all local fair chance ordinances regarding employment eligibility.