Quality Specialist

About the role

This position serves as an individual contributor within the Quality Unit, focusing on oversight in a sterile injectable 503B and cGMP environment. You will manage daily quality operations, including batch record reviews, environmental monitoring, and investigations to ensure compliance with 21 CFR and USP standards.

Key facts

What you'll do

• Monitor manufacturing and aseptic processing on the floor to ensure adherence to cGMP and USP procedures.
• Verify batch documentation, testing, and investigation completion to facilitate product disposition.
• Review and update specifications, master batch records, and controlled forms.
• Oversee the environmental monitoring program and address adverse trends or excursions.
• Manage packaging and labeling controls to prevent errors.
• Inspect incoming materials and handle COA reviews.
• Coordinate with contract laboratories and manage vendor quality oversight.
• Author and manage SOPs within the document control system.
• Conduct root cause analysis for deviations, OOS, and CAPAs.
• Assist with internal and regulatory audits to maintain inspection readiness.
• Compile data for Annual Product Quality Reviews.

Requirements

• 2+ years of experience in QA or QC within an FDA-regulated setting.
• Direct experience with sterile injectable cGMP or 503B outsourcing facilities.
• Knowledge of FDA cGMP (21 CFR Parts 210, 211, and 11) and Section 503B of the FD&C Act.
• Proficiency in USP-NF standards, including <795>, <797>, and <800>.
• Experience with aseptic processing, contamination control, and ISO 14644 principles.
• Background in batch record review and product disposition.
• Experience managing deviations, CAPA, change control, and investigations.
• Ability to perform risk assessments and statistical trend analysis.
• Technical writing and documentation skills.

Nice to have

• Experience with electronic Quality Management Systems, specifically Trackwise.

Skills & tools

• Microsoft Office Suite (Word, Excel, Visio, PowerPoint, Outlook)
• Electronic QMS (Trackwise)

Practical notes

• Benefits include unlimited PTO, quarterly mental health days, medical/dental/vision coverage, parental leave, 401k with matching, and an Employee Stock Purchase Program.
• The company provides reasonable accommodations for applicants with disabilities; inquiries can be sent to accommodations@forhims.com.
• This role operates under fair chance hiring laws in Los Angeles and California.