Quality Documentation Specialist

QUALITY DOCUMENTATION SPECIALIST JOB OVERVIEW Multi-Pak Packaging is a trusted partner to leading companies in the healthcare industry. We provide clients with labeling and packaging options as well as comprehensive supply chain solutions.

Under the direction of the Quality Control Manager, the Quality Documentation Specialist ensures that products adhere to a defined set of quality standards and meet the requirements of customers.

This position is responsible for the cGMP documentation, review, verification, and development of all Master Batch Records and Quality Records used in the contract packaging operations at MP in accordance with the company’s SOPs and Client Specifications.

RESPONSIBILITIES:Essential Functions:· Attend New Product Meetings· Create, Verify and Update Master Batch Record Templates used for Production (Primary and Secondary)· Management of Master Batch Record Logbook· Review Client Specific information provided for Batch Records (Warehouse Issuance/ Returns, Reconciliation)· Draft PO Specific information and other vital information from Client Specifications (Work Order, Start up check, In Process Checks, Pallet tag information, and Pack Out instructions)· Review and verify the receipt of New Product Evaluation form including Stability Documents, COA, and Receiving Reports · Create and Verifies Shipper Labels· Issue approved Batch Records (PO Specific) to Quality Office prior to production· After production, verify accuracy and completeness of Batch Record· Complete Final Reconciliation · Issues Certificate of Conformance (COC) for the release of finished goods.· Ensure timely release of Batch Record· Provide all requested and or required documentation to the shipping department· Provide all completed final reconciliation to inventory· Key person responsible for the review, and management of records this includes: · Verification of accuracy and completeness of documents to ensure cGMP · Electronic scanning and physical archiving of Batch Records· Assist and facilitate internal investigation / deviations associated with batch records· Assist in the management of Annual Product Review recording.· Provide Client support and Email Completed Batch Records to select ClientsNonessential Functions/Demands:• Backup and assist in all areas of Quality, on an as needed basis.• May be asked to assume adhoc responsibilities in support of Quality functions.• Assist with FDA and other regulatory agency inspections as needed.• Perform other related duties as assigned. • Assist in MP annual inventory QUALIFICATION REQUIREMENTS:• 1-3 years’ experience in a pharmaceutical and/or nutritional supplement industry.• Bachelor’s degree in a technical field (preferred not required); Minimum of Associate degree or working towards the completion in a field such as finance/ accounting, logistics and / or manufacturing.• Data Entry experience.• Excellent attention to detail.• Understanding of solid dose packaging and labeling Operations as associated with Dietary Supplement or Prescription Drugs. • Experience working with Contract Packaging Organizations (preferred not required). • Must be self-motivated and able to work independently with a team-focused attitude.• Knowledge and understanding of FDA CFR 210 & 211 cGMP regulations.• Possess the ability to communicate and explain processes and / or issues.• Must have the ability to work in a dynamic work environment.• Ability to understand and advocate for Quality processes.• Ability to assess and resolve issues that falls within scope of responsibilities.• Excellent verbal, written, and interpersonal communication skills.• Excellent Word and Excel skills, as the job requires manipulation of templates in excel, as well as interpretation of client specifications and report writing.REPORTING RELATIONSHIP:• Manager : Quality Documentation ManagerManager• Managerial Responsibility: none