Quality Inspector II
Weekend Shift - Days - Thursday - Friday 7:00AM-3:30 PM and Saturday - Sunday 7:00AM- 7:30PM
Kelly has provided outstanding employment opportunities to the most talented professionals in the marketplace. Today, we are proud to offer an excellent contract opportunity for a Quality Inspector with our client, a leader in the medical device industry, located in Tampa, Florida
Objectives: The assurance of quality product and batch records from the manufacturing departments. Evaluates quality issues with Manufacturing and Quality Assurance.
Follows standard operation procedures and review to batch records to ensure compliance with Good Manufacturing Practices (GMP), accuracy, completeness, and accountability.
Monitor and conduct in process inspections in the manufacturing area, implementing proper documentation practices, applicable visual inspections, testing intervals and/or methods, as per batch record instructions and current SOP.
Properly identifies suspect material and performs segregation procedures, or when instructed by QA management and/or per provided written instructions.
Check batch documents to ensure product, lot number, expiration dates and all components are correct, and conducts on line reviews.
Performs AQL sampling and documents inspection results in the batch record.
Performs LOTO, product inspections, and line clearance duties per procedures. Performs shift change line verification.
Pull in-process sampling and deliver accordingly.
Interacts with other departments including Materials Management, Contract Manufacturing, Engineering and Validation. Assists and executes protocols and studies.
Identify and inform applicable departments in the event of a potential or observed nonconformance.
Assist the manufacturing team with the issuance, correction and review of batch documents.
Assist Manufacturing team as needed with batch record reviews and batch record closure on each line at the end of the run including accountability and yield calculations.
Completes all required documentation review and work with the Manufacturing team to resolve outstanding issues before releasing to Quality Assurance.
Evaluates quality issues and assists with the investigations providing necessary information and documentation when needed.
Supports and actively participates in standardization and Quality metrics.
Support of manufacturing schedules and changes.
Assume the responsibility for the GxP, ISO, and environmental health and safety procedure awareness and compliance within the respective area.
Maintain compliance to GxP and procedural reading; personal development.
Qualifications: Associates degree preferred. High School Diploma Required.
This position requires quality control/assurance experience. Ability to work well with people an independently. Be able to follow written and verbal instructions and ability to read and understand SOP's. Excellent time management skills and attention to detail is critical. Maintain QC, line clearance and if assigned, aseptic gowning certifications. Able to work independently with little supervision. Ability to solve shop floor issues per procedures and utilizing analytical and critical thinking skills.
3+ years of pharmaceutical/FDA regulated facility or related field required.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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