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Pharma Quality Line Inspector

Ultimate

This is a Contract position in San Clemente, CA posted August 6, 2021.

This role is in the clean-room full time ensuring and performing in-process Experience working in a clean room and/or performing in-process assembly and manufacturing verification inspections. The quality control inspector is responsible for verifying manufacturing production/packaging lines run smoothly and generate consistent safe quality product for the company.MUST HAVE MEDICAL DEVICE OR PHARMA EXPERIENCE!Responsibilities:Consistently records quality related results in accordance with prescribed good documentation practices requirements.Determines the need and executes the halting of operations due to adverse quality conditions in an effective and timely mannerPerforms final review and approval of line clearance activities.Performs product and component verification prior to, during and subsequent to production activities.Execute verification of product/component against approved quality document or record.Continuously assesses, enforces and report cGMP compliance events at the operational level.Executed AQL sampling for at least two lines.Performs required in-process/finished goods testing.Real time Batch Record review for at least two lines.Conduct manufacturing line clearances and verifications of in-process and final product.Initiate Non-Conformance and CAPA investigations.Consistently use the Quality System Standards, Quality System Regulations, and other company procedures around which the Quality System is developed.Maintain a safe work environment by following good housekeeping and company guidelines for safety; ability to use tools and equipment safely.Work Experience: Level – IIAt least 3 years of medical assembly experience in a medical device company.Knowledge, Skills, and AbilitiesMedical device experience and working knowledge of QSR a mustExperience working in a clean room and/or performing in-process assembly and manufacturing verification inspections desirableAttention to detail and accuracy a mustMust have excellent documentation skillsTeam player, good written/oral communicatorMust be organized and able to coordinate activities with outside vendorsFamiliar with AQL(Acceptable Quality Limit) sampling or sampling plans in general, visual and dimensional inspection.Ability to work in a fast-paced environment.Basic inspection knowledge with 1 to 2 years experienceWe are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.