Specialist, Compounding Operations Documentation

New Albany, Ohiofull time

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Remote

mid

H1B: no

Hims and Hers Specialist, Compounding Operations Documentation responsible for creation, review, control, and improvement of documentation related to compounding activities. Ensures compliance with USP standards and internal quality systems.

Responsibilities

Draft, revise, and format manufacturing documentation including SOPs, work instructions, logs, forms, and compounding protocols
Control, approve, and issue document revisions per document control procedures
Maintain documentation archives with real-time filing and retrieval
Ensure documentation aligns with FDA, EU, USP, and internal QMS standards
Participate in audits and inspections by preparing and presenting documents
Support data integrity initiatives adhering to ALCOA+ principles
Collaborate with production and quality teams to improve documentation processes
Partner with compounding operators and supervisors for training identification
Help transition paper-based processes to electronic formats

Qualification

Strong knowledge of USP 795 and 800Document control systems (e

Required

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

Preferred

Working familiarity with compounding processes, equipment, and terminology.
Experience in electronic batch records (EBR) and manufacturing execution systems (MES).
Ability to handle multiple priorities with a strong sense of urgency and accuracy.
Strong interpersonal and communication skills, especially when liaising between Compounding and QA teams.
Good Manufacturing Practices (cGMP) experience.
3–5 years of experience in a cGMP manufacturing environment, preferably with compounding or formulation experience.
Document control systems (e.g., MasterControl, Veeva, Agile) experience.
Work Environment & Physical Requirements:

Benefits

Dental
Vision
401(k)
PTO
Equity/RSU
Parental Leave
Wellness

Company

Hims and Hers

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Source: ashby

Active within the past hour

Remote-friendly

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