Quality Clerk
Job
US_MPC_1000 Menasha Packaging Company , LLC
Lebanon, IN (In Person)
Full-Time
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Job Description
Menasha Corporation Employees, please log-in to your Workday account to apply for positions.
ABOUT US
(ANDOUR EXCITING FUTURE
) Menasha Corporation is all about possibilities. Our two businesses, Menasha Packaging and ORBIS Corporation, are leaders in their industries, providing corrugated and plastic packaging products and related services to major global companies. Our employees make the difference, proving that great ideas, collaboration and quality turn possibilities into success. Working at Menasha Corporation means that your insights provide cutting-edge solutions for our customers. If you like to make things happen and are passionate about what you do, you're going to want to be here. Join us and become part of the power behind possible. About The Opportunity Under the general supervision of the Document Supervisor, the Quality Clerk supports the quality and production departments in all GMP compliance document related matters and ensures that batch records comply with GMP, regulatory requirements and Menasha Packaging Company requirements. Essential Job Functions The following duties are normal for this position. The incumbent may perform some or all of these duties however; it is not an exclusive or all-inclusive list. Other duties may be assigned. Provides comprehensive quality review of batch records ensuring that all aspects of the handling and packaging at the site comply with the requirements of the customer and meet all relevant GMP, regulatory and Menasha's requirements Ensures that batch record review contains the approved deviations, is managed to the required timelines, and that issues are corrected in a manner that is sustainable Identifies discrepancies and works to obtain correction of the discrepancies with the responsible individual(s) Communicates issues from review with Production and Management Confers with Document Supervisor and/or production supervisors/managers on issues regarding batch records for resolutions Generates Certificate of Conformance per customer requirements Releases batch records into WMS by entering the date code information and changing the status from "Hold" to "112" - follows necessary steps to verify that the release process is accurate and that product used is not in "Block" or "Quarantine" status Completes release process after Inventory posts production Files completed batch records as per client level Required Functions Release Finished good in WMS. Use WMS to determine product status Use Excel-based reports to report batch record discrepancies Use jet reports Use Microsoft Outlook to communicate to customers and other Menasha team members Supplemental Functions Creates batch record related folders in appropriate computer drive that allows other personnel to access at any given time Education & Experience Minimum 2 + years related experience in a GMP regulated environment High School Diploma/GED desired. Knowledge, Skills & Abilities Strong knowledge of FDA regulations, cGMP regulations, and Safety- Strong knowledge of MS Outlook, Word, and Excel
- Excellent communication, management and technical writing skills
- Proficient in the English language.
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