Packaging Reconciliation Coordinator

Job Summary:

To account for all issued, returned, and scrapped labeling/printed components (tray, bottle, lidding labels, inserts, etc.) from the packaging lines and reconcile usage documented in the packaging record.

Duties and Responsibilities:

• Promote a safe, GMP/SOP compliant environment, ensuring product integrity, within an FDA regulated pharmaceutical manufacturing facility.
• Ensure that all required documentation in the packaging record and/or Master Label Record during the packaging process is complete, accurate, and compliant.
• All labeling material quantities issued, used, and returned from the packaging order/lot must be verified and documented in the packaging record.
• Determine and verify the total number of issued labels and depleted labels, and document in the production record and/or master label record.
• Determine, calculate, and verify the percent accountability for each item that was used for the lot and document in the packaging record.
• Disposition components in accordance with the appropriate specifications and procedures. Perform the appropriate computer transactions for tracking packaging records.
• Manage the printed component issuance and return area. Return labeling items as per the labeling / printed components storage requirements.
• Develop a working knowledge of statistical sampling, calculation, and their application to determine accountability.
• Develop a working knowledge of cGMPs, SOPs and FDA / DEA regulations
• Segregate, quarantine and complete the documentation for non-conforming materials.
• Review and sign Packaging Records prior to releasing to Quality, including assignment and verification of the percent of accountability / reconciliation.
• Work “cross functionally” with Departments, when necessary, to identify the cause and appropriate corrective action for any issues that are discovered. Document all such occurrences in the batch production record.
• Daily warehouse management transactions for amount verifications, bin transfers, approvals, spot counts, and amendments
• Destruction of Packaging Materials and maintenance of a DOM log.
• Assist in Packaging operations and any other jobs / duties as assigned by management.

Required Skills/Abilities:

• Ability to work overtime as required.
• Ability to perform the physical tasks associated with sampling and inspecting.
• Must be organized, reliable and detailed oriented.
• Needs to be able to multi-task, prioritize, and communicate effectively.
• Must be able to lift and carry up to 30 lbs.
• Understanding of Standard Operating Procedures and Good Manufacturing Practices and Good Documentation Practices. as related to work activities
• Basic Computer skills to include the use of Email, Red Prairie, MS Word and MS Excel
• Operate a hand truck, label counter, barcode scanner, scale / balance and scientific calculator.

Education and Experience:

• High school diploma, GED, or equivalent
• 1+ years of Packaging and/or QA experience in a manufacturing environment is preferred.

Physical Requirements/ Working Conditions:

• Manufacturing, packaging and warehouse production areas.
• Walking
• Gowning requirements.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify. PAI Pharma is a nicotine-free campus, meaning the use of nicotine products - including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances - is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees. EEO Employer / Veteran / Disabled