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Quality Associate

Company: Aerotek
Location: Stanley
Posted on: January 15, 2022

Job Description:

Description:Position Summary:This positions essential function is to provide shop floor quality support to the manufacturing group. MQAs will provide review records, support maintaining of prescribed housekeeping standards, and liaise with manufacturing personnel to ensure compliant and timely cGMP manufacturing. Job Responsibilities: oPartner with shift production supervisor to identify and resolve quality issues in support of ongoing, right-first-time manufacturing. This includes investigating issues and collecting supporting information and documentation to initiate deviations. The ability to accurately and timely document events is a critical function of this role.oWorks as a liaison between Quality and Manufacturing to insure manufacturing processes are compliant with cGMP standards.oPerform quality monitoring, to include packaging startup checks and release, ongoing quality inspections, and other quality monitoring of the manufacturing area, as requiredoConduct batch record and other document reviews at defined intervals and work with appropriate personnel to correct errors impacting batch release prior to advancing the records to the next review level oPull raw material samples and tag RMs and components for release; perform general troubleshooting of receipt issuesoCollaborate with shift supervisor and manufacturing personnel to maintain an exceptional level of housekeeping throughout facility; escalate unresolved concerns to management, as appropriate oPull labels for process orders; Perform label accountability calculations and investigate as needed.oPerform raw material verifications for compounding recordsoSupport continuous improvement efforts oOther tasks as directed by supervisor or to support the needs of the businessRequired Qualifications:Practical Exposure to quality systems (sampling, testing, reviewing, approving) Five years manufacturing experience in a cGMP environment.Proficiency in Microsoft Excel and Word. Excellent organization and time management skills Must be able communicate: issues, troubleshooting actions, and resolution options effectively; strong grammar and proofreading/editing skills are required.Must be able to stand for extended periods of time, squat, grasp, lift containers in excess of 20 lbs. Wear PPE as required by the work area. Demonstrated ability to perform basic math functionsPreferred Skills and Qualifications: Able to independently solve problems and make decisions based on company and/or quality policy.Demonstrated ability improve and refine processes; Exposure to continuous process improvement tools like: green belt, 5S, Kaizen, Lean 6 sigma.Demonstrated problem solving skills.Ability to both work in teams and independently and make objective decisions.Must be quality-oriented and possess the ability to consistently maintain an exceptional level of attention to detail.Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that cGMP and regulatory requirements are met.Skills:Quality assurance, Gmp, Sop, CAPA, fda, documentation control, batch record, batch review, inspection, visual inspection, documentation, quality, qa, cgmp, quality check, safety, data entry, audit, regulatory, batch record reviewTop Skills Details:Quality assuranceAdditional Skills & Qualifications:Practical Exposure to quality systems (sampling, testing, reviewing, approving) Five years manufacturing experience in a cGMP environment.Proficiency in Microsoft Excel and Word. Excellent organization and time management skills Must be able communicate: issues, troubleshooting actions, and resolution options effectively; strong grammar and proofreading/editing skills are required.Must be able to stand for extended periods of time, squat, grasp, lift containers in excess of 20 lbs. Wear PPE as required by the work area. Demonstrated ability to perform basic math functionsExperience Level:Intermediate Level About Actalent:Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. Were supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Gastonia , Quality Associate, Other , Stanley, North Carolina

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