Quality Auditor Associate

Job Description

Job Summary (Materials and Samples):

• Handling of pharmaceutical drug products, including topical patches, ointments, gels, and creams, as well as an oral liquid dosage form (oral suspension), as well as some combination products such nasal sprays, pump products, and vaginal applicators.
• Our drug products include non-controlled substances as well as some DEA controlled substances (schedule III and IV), as well as hormones.

Duties and Responsibilities:

• Perform sampling and delivery of intermediate and finished products.
• Assist with retain sample management.
• Conduct monthly GMP and batch-specific room audits.
• Perform in process record review of commercial manufacturing batch records.
• Review completed swab data and perform subsequent room/equipment release.
• Ensures compliance with all Company policies and procedures, including safety rules and regulations.
• Performs related duties as assigned.

Education/Certification/Experience:

• Requires a minimum of 1 year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.
• Requires basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.
• Associate’s degree or higher (or equivalent) achieved or in process preferred.

Knowledge, Skills & Abilities:

• Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), EDMS, and ERP systems.
• Self-directed with ability to organize and prioritize work.
• Ability to communicate effectively with excellent written and oral communication skills.
• Ability to interact positively and collaborate with co-workers and management.