Manufacturing Quality Assistant

Fagron Sterile Services • Wichita, KS • 10h ago

This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13591827

Who we are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries. The goal of Fagron is: Together we create the future of the personalized medicine. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient. From our position as market leader, we act locally and think internationally.

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:

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.

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?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities. Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. Fagron US is proud to be an affirmative action and equal opportunity employer.

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