GMP On-Floor Quality Assistant

Fagron; Wichita (KS); On-site; USD 50,000 - 65,000; Full time

Job summary

Fagron US is seeking a Manufacturing Quality Assistant to ensure GMP-compliant manufacturing processes. You will be on the floor for line clearances, visual inspection tasks, deviation/ CAPA support, and on-going investigations. Daily duties vary with shifting priorities.

Ideal candidates have 2+ years pharma quality experience, a background in GMP environments, and the ability to maintain clean room qualifications. Strong communication and multitasking skills are essential in this role.

Qualifications

• 2+ years Pharma experience with Quality experience preferred.
• Experience in a regulated GMP environment.
• Ability to be clean room qualified and maintain qualification.
• Detail oriented with strong verbal and written communication skills.
• HS Diploma, Bachelor’s degree preferred.

Responsibilities

• Be able to enter CNC areas to perform all MQ functions as needed.
• Support 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.
• 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 in a tactful manner.
• Assist with multiple project tasks at once with changing deadlines and priorities.
• Communicate shift and business needs with leads, pharmacists and colleagues to ensure priorities are met.

Skills

Pharma experience

Quality systems

GMP

Clean room qualification

Attention to detail

Verbal and written communication

Visual inspection

Education

HS Diploma

Bachelor’s degree preferred

Job description

Fagron US is seeking a Manufacturing Quality Assistant to ensure GMP-compliant manufacturing processes. You will be on the floor for line clearances, visual inspection tasks, deviation/ CAPA support, and on-going investigations. Daily duties vary with shifting priorities.

Ideal candidates have 2+ years pharma quality experience, a background in GMP environments, and the ability to maintain clean room qualifications. Strong communication and multitasking skills are essential in this role.