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.
QA Assistant
Responsibilities
- Review Certificate of Analysis for incoming goods and verify associated documentation
- Visually inspect all incoming goods to ensure that the packaging is not damaged, and that quality of the product is not compromised by the condition of the package
- Physically inspect packaging components to ensure all items meet quality standards
- Sample incoming goods (packing components and Active Pharmaceutical Ingredient)
- Send samples of API to third party lab for testing
- Track status of API samples sent to third party lab for test results
- Review lab test results to ensure that sampled products meet quality standards
- Release products and API that meet quality standards
- Use AX to complete checklists and input data as needed
- Revise and create SOPs for incoming quality processes
- Initiate investigations for Incoming Quality
- Communicate and collaborate with Supply Chain, Production, Quality, and Quality Control on all Incoming Quality processes and the release status of raw materials tested for quality
- Data entry for raw material test results, incoming material inspection reject rates, and supplier qualification and management.
- New item setup in AX.
- 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
Requirements
- BS in science or 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