About the job
Candidate will work with Quality Assurance as a Quality Assistant to ensure compliance of manufacturing processes in a GMP environment. This person will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project orientated, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.
- Review lab data, validation and stability protocols/documents, batch records, specifications, and manufacturing orders for compliance
- Support manufacturing through timely process of deviations, change controls, CAPA complaint handling, and investigations to ensure quality products
- Conduct facility and/or supplier assessments, raw material release, and line clearances
- Author and update SOPs as needed
- Follow GMP guidelines and adhere to SOPs and GMP requirements
- Communicate QA issues to employees and managers in a tactful manner
- Work on multiple projects at once with changing deadlines and priorities
Set yourself apart
You possess the following qualifications, background and abilities:
- BS in Chemistry or related science with 2-6 years of applicable experience
- Experience working in a laboratory or process manufacturing setting
- Experience working in a regulated environment (GMP)
- 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?
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.