Quality Clerk
Menasha Corporation, Lebanon, PA, United States
Quality Clerk
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
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. Bilingual (English/Spanish) preferred
Excellent organizational skills as well as attention to detail
Analytical abilities (solid math skills)
Aptitude to analyze, organize work and to set priorities to meet deadlines
Ability to work overtime when needed
Physical Requirements & Work Environment
Primarily works in a production and/or warehouse setting with time spent in an office setting
Required to stand up and/or sit down 8 plus hours a day
Must be able to lift up to 25 lbs. on occasion
Must be able to reach, squat, stoop, bend
Must have physical dexterity of hand and fingers
All Menasha Packaging employees must conduct their work in a manner that complies with all legal standards and meets customer expectations. They will maintain quality standards by establishing, enforcing and adhering to organizational standards set forth in published policies, procedures and processes.
Menasha Packaging is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, the company will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective employees and incumbents to discuss potential accommodations with employer.
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
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. Bilingual (English/Spanish) preferred
Excellent organizational skills as well as attention to detail
Analytical abilities (solid math skills)
Aptitude to analyze, organize work and to set priorities to meet deadlines
Ability to work overtime when needed
Physical Requirements & Work Environment
Primarily works in a production and/or warehouse setting with time spent in an office setting
Required to stand up and/or sit down 8 plus hours a day
Must be able to lift up to 25 lbs. on occasion
Must be able to reach, squat, stoop, bend
Must have physical dexterity of hand and fingers
All Menasha Packaging employees must conduct their work in a manner that complies with all legal standards and meets customer expectations. They will maintain quality standards by establishing, enforcing and adhering to organizational standards set forth in published policies, procedures and processes.
Menasha Packaging is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, the company will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective employees and incumbents to discuss potential accommodations with employer.