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 Quality 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
• Completes other duties as assigned

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.

The above statements reflect the general details necessary to describe the principle functions of the occupation described and shall not be construed as a detailed description of all the work requirements that may be inherent in the occupation.

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.