Manufacturing Quality Assistant
Fagron Sterile Services US (FSS) · Wichita, KS · 4 wk ago
Quality AssuranceFull-time
About the job
Work with Quality Assurance as a Manufacturing Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. Serve as on the floor presence for line clearances, visual inspection performance, investigation support, deviation/CAPA closure. Every day may be different with changing responsibilities and priorities.
Key Responsibilities
- Enter CNC areas to perform all MQ functions as needed.
- Serve manufacturing through an on the floor presence for line clearances, resolution of issues or elevation.
- Perform AQL of visual inspection and labelling operations.
- Assist in facility and/or supplier assessments and raw material/component release.
- Absorb and update applicable SOPs as needed.
- Follow GMP guidelines and adhere to SOPs and GMP requirements.
- Communicate QA issues to employees and managers in a tactful manner.
- Absorb and communicate shift and business needs with leads, pharmacists and colleagues to ensure priorities are met.
Set yourself apart
- 2+ years Pharma experience with Quality experience preferred.
- HS Diploma, Bachelors 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.
- Have 20/20 vision, correctable with glasses/contacts.
- Be able to be visual inspection qualified and maintain qualification.
- Detail oriented, ability to get along with a variety of different personalities, multitasking skills, and works well under pressure.
- Strong verbal and written communication skills.
- Technical writing and review ability.
- Desire to work in an office setting as this position is not laboratory focused.
What's on offer?
- Competitive salary
- Comprehensive benefits
- Performance package
- Ability to be part of an international leader in an expanding industry