Perform in-process inspections using a variety of measuring and test equipment to determine acceptance or rejection of material or products being produced.
Perform line clearances and quality reviews in manufacturing, labeling or other assigned areas during manufacturing activities.
A requirement of the role includes working in classified clean rooms. Must be present in assigned production area for the duration of the shift.
Responsible for maintaining gowning qualification and for setting the standard for clean room behavior.
Interpret and work within the guidelines of specifications, charts, procedures and other data to determine acceptance or rejection of materials or products.
Maintain records of inspection and all testing performed on the appropriate test records
Discuss inspection results with those responsible for the product. Coordinate and inform other departments of inspection and/or testing status in support of production and project goals and initiatives
Monitor operations to ensure that production standards are met. Escalate discrepancies to management for remediation.
Regularly review and maintain manufacturing log books and forms.
Identify and implement opportunities for continuous improvement, including document revisions in order to maintain accurate SOPs.
Maintain the QC inspection areas in an orderly fashion conducive to carrying out safe and efficient inspections and procedures.
Assist in training new associates according to QSR and company SOPs as applicable
High School diploma (or GED). College education is preferred.
2-5 years of relevant GMP/GLP experience specific to line-clearance and in-process inspections.
QA experience in the medical device or pharmaceutical industry is preferred.
Experience working in classified cleanrooms is preferred.
Attention to detail, strong organizational skills, and time management are essential.
Must have strong communication skills-both written and verbal. Must effectively communicate with other departments and have strong intrapersonal skills.
Must be self-directed, with strong problem solving skills.
Working knowledge of ISO 13485, 21CFR820 FDA QSR, and cGMP
Knowledgeable in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook), a plus.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to work effectively in a cross-functional environment.
Ability to integrate quality objectives across multiple functions
Must be able to work independently with minimal supervision.