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The Quality Assurance Assistant will ensure compliance of manufacturing processes in a GMP environment and will serve as reviewer and/or approver for required documentation in a plant setting. This position is very project-oriented, so the QA Assistant can expect every day to be different with changing responsibilities and priorities.
Job Responsibility:
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
Requirements:
High School equivalent is required
associate or bachelor's degree in a science related field is preferred
Experience working in a manufacturing or laboratory setting
Ability to work in a regulated environment (cGMP)
Detail oriented
Ability to work both independently and interdepartmentally
Ability to multitask
Ability to be cleanroom gowning trained and ability to maintain gowning qualification
Strong verbal and written communication skills
Technical writing and review ability
What we offer:
competitive salary
comprehensive benefits
performance package
ability to be part of an international leader in an expanding industry