Packaging Reconciliation Lead

JOB SUMMARY:

Leads and performs a variety of process duties according to batch record and Standard Operating Procedures (SOP's) in the pharmaceutical manufacturing department, accounting 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. The essential duties and responsibilities listed below are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities.

ESSENTIAL DUTIES AND RESPONSIBILIITIES:

• Follows all policies, procedures, and State, Federal and Local laws. 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 in SAP.

• 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, verification in SAP.

• 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 SAP and 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 in records and SAP.

• Destruction of Packaging Materials and maintenance of a DOM log.

• Assist in Packaging operations and any other jobs / duties as assigned by management

• Troubleshoots any errors, competent in troubleshooting process issues.

• Communicates and coordinates issues with Packaging Department.

• Supervises other Reconciliation Coordinators to ensure continuity, follow up, and closure of records to QA Release Department within 3 days of Packaging completion

• Interfaces with Quality and Supervisors to inform of deviations or other record documentation issues.

• Fill in when Reconciliation Coordinators are absent.

• Organize work of Packaging Reconciliation Coordinator(s) on assigned shifts. Answer questions, provide direction and training.

• Prepare packaging line for production by confirming line clearance. Ensure documentation is completed per batch record and SAP.

• Other duties as assigned.

EDUCATION AND/OR EXPERIENCE:

• High school diploma, GED, or equivalent

• 2+ years of Packaging and/or QA experience in a manufacturing environment is preferred.

• SAP experience - preferably SAP Super User

• 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

• Familiarity with Food and Drug Administration (FDA), and other regulatory requirements. Understanding of SOP's documentation and safety practices.

• Establishes and maintains cooperative working relationships with others.

• Responsible for full operation of Packaging Documentation.

• SAP and Microsoft software experience is required.

QUALIFICATIONS AND/OR ABILITIES:

Excellent communication skills and the ability to recognize effective communication styles. Must manage shifting priorities in a dynamic operations setting. Strong problem-solving skills and the ability to executive corrective measures rapidly. Must have working knowledge of the liquid fill Packaging processes. Will recognize deviations from OSHA compliance on the operations floor and Warehouse.

PHYSICAL REQUIREMENTS/WORKING CONDITIONS:

The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g. computers, phones, etc.). Continuously required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. The employee must occasionally lift and/or move up to 40 lbs..

PAI is an Equal Opportunity Employer. PAI uses E-Verify.

EEO Employer / Veteran / Disabled