Responsibilities include, but are not limited to, conducting component and product testing, monitoring process controls,participating in failure investigations and verifying environmental monitoring data entry.
Execute component and product testing.
Review and ensure compliance of all Quality Records.
Ensure that non-conformances relating to environmental controls, processing controls, validations, and any other quality issues are handled in a timely and effective manner.
Maintain a sound understanding of the Quality System Regulations and ISO Standards as they pertain to the entire operation (i.e., non-conformities, Good Documentation Practices, Acceptance Sampling, product storage and identification, etc.).
Ensure that materials for use in product processing are properly identified and controlled and meet the required dimensional, physical, and visual specifications prior to release.
Confirm that equipment and supplies are properly utilized and, where appropriate, calibrated to meet schedules with maximum productivity at the lowest intermediate and long-range costs within budget standards.
Perform complex inspections requiring specialized measurement equipment, such as calipers, micrometers and Instron testers. Complete and maintain the inspection documentation, evaluate the data and, where necessary, prepare preliminary reports.
Bachelor's degree, preferably in a Life Science field, or equivalent work experience.
Minimum of 1 year of experience, preferably within the quality function of a regulated industry with knowledge of ISO Standards, cGMPs and the Quality System Regulations.
Computer skills including word processing, spreadsheets and data analysis.
Understanding of the use of mechanical inspection equipment, such as calipers, micrometers and Instron testers and
understanding of engineering drawings, procedures and specifications.
Strong communication and mathematical skills.
Ability to prioritize numerous projects and responsibilities, to make decisions efficiently and to work with minimal
Team player with ability to adapt easily.