Compounding Documentation Specialist (cGMP/USP)

hims & hers; New Albany (OH); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary & equity

Unlimited PTO

Comprehensive health benefits

401k with employer matching

Employee stock purchase program

Job summary

Hims & Hers in New Albany, OH is seeking a Compounding Operations Documentation Specialist to draft, revise, and maintain manufacturing documentation, including SOPs, work instructions, logs, forms, and compounding protocols, in support of regulated production. You will ensure revisions are controlled, archives are kept, and documentation aligns with FDA and USP standards.

The role involves audits, ALCOA+ adherence, training collaboration, and transitioning paper processes to electronic formats

Qualifications

• Bachelor’s degree in English/Communications, Technical Writing, Pharmaceutical Technology, Chemistry, Pharmacy or related field.
• Strong knowledge of USP 795/800, cGMP, GDP and compliance.
• Detail-oriented with proofreading and technical writing skills.
• Proficiency in Google Suite; experience in Asana, SmartSheet.

Responsibilities

• Draft, revise, and format SOPs, work instructions, logs, forms, and compounding protocols.
• Ensure revisions controlled, approved, issued per procedures.
• Maintain archives with real-time filing and retrieval.
• Participate in audits and inspections by preparing and presenting relevant documents.
• Support data integrity initiatives and ALCOA+ adherence.

Skills

Documentation

Attention to detail

Communication skills

Regulatory knowledge

GXP/compliance

Education

Bachelors in English/Comm

Tools

Google Suite

Asana

SmartSheet

Job description

Hims & Hers in New Albany, OH is seeking a Compounding Operations Documentation Specialist to draft, revise, and maintain manufacturing documentation, including SOPs, work instructions, logs, forms, and compounding protocols, in support of regulated production. You will ensure revisions are controlled, archives are kept, and documentation aligns with FDA and USP standards.

The role involves audits, ALCOA+ adherence, training collaboration, and transitioning paper processes to electronic formats