Manufacturing Quality Assistant

Fagron is the global market leader in pharmaceutical medicine, with products sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: Together we create the future of personalized medicine. Fagron collaborates with prescribers, pharmacists, and customers to improve medications and help patients.

About the role

Work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. Serve as an on-the-floor presence for line clearances, visual inspection performance, investigation support, deviation/CAPA closure. Responsibilities and priorities may change daily.

Responsibilities

• Enter CNC areas to perform all Manufacturing Quality (MQ) functions as needed.
• Support manufacturing through an on-the-floor presence for line clearances, issue resolution, or escalation.
• Perform AQL of visual inspection and labeling operations.
• Assist in facility and/or supplier assessments and raw material/component release.
• Assist in authoring and updating applicable SOPs as needed.
• Follow GMP guidelines and adhere to SOPs and GMP requirements.
• Communicate QA issues to employees and managers tactfully.
• Manage multiple project tasks with changing deadlines and priorities.
• Communicate shift and business needs with leads, pharmacists, and colleagues to ensure priorities are met.

Requirements

• 2+ years of pharmaceutical experience with Quality experience preferred.
• High School Diploma; Bachelor’s degree preferred.
• Experience working in a laboratory or process manufacturing setting.
• Experience working in a regulated environment (GMP).
• Ability to be clean room qualified and maintain qualification routinely.
• 20/20 vision, correctable with glasses/contacts.
• Ability to be visual inspection qualified and maintain qualification.
• Detail-oriented with strong multitasking skills and ability to work well under pressure.
• Strong verbal and written communication skills.
• Technical writing and review ability.
• Desire to work in an office setting (this position is not laboratory-focused).

Benefits

We offer a dynamic environment where talent and ambition can develop fully. Fagron provides an open and informal organizational culture, competitive salary, comprehensive benefits, and a performance package. This role offers the opportunity to be part of an international leader in an expanding industry.