Label Control and Packaging Supervisor

This position is responsible for supervising Nivagen label control and packaging area. Works in SAP system and Quality system to perform inspection testing of incoming labelling and packaging components. Supervising the packaging team to provide oversight of Packaging and making sure that AQL’s support finished product release. The position is a liaison with the warehouse, customer service and manufacturing for incoming goods both finished product and incoming components. The position is responsible for implementing Nivagen inspection and testing quality standards for labelling and incoming packaging components, while leading the packaging QA team to meet Nivagen timelines.

ESSENTIAL DUTIES AND RESPONSIBILITIES

1. Manage the Label Control Program ensuring that finished product is appropriately labeled to the correct versions and timelines. This includes management of specifications, inspections, and release of labelling in SAP.
2. Manage the Packaging Component Specification program by obtaining documentation for components that have product contact from project managers, engineers, or purchasing.
3. Prepare or review change controls to introduce product/components into Nivagen Quality System.
4. Develop quality inspection criteria for finished products to include label review, temperature requirements, and destructive testing for quality attributes, if applicable.
5. Create documentation for Quality inspection of each packaging component against supplier drawings, supporting documentation and physical testing.
6. Work with Engineer and Operations for component acceptability testing on the line in conjunction of writing component specifications for approval.
7. Sample and inspect incoming drug products and/or components against quality standards. Record and review documentation for accuracy and completeness.

1. Maintain the initial and final documentation in the electronic management system.
2. Disposition product/component after quality review of inspection criteria
3. Set up metadata in SAP of new drug products and establish workflows for inspection criteria in the documentation quality system.
4. Interact with Purchasing and Supplier for investigations into non conformances, writing deviations, and SCAR reports.
5. Track labelling and packaging components supplier performance and assist in quality agreements.
6. Maintain all working areas in a clean and orderly state. Assure products are stored, segregated and clearly labeled.
7. Ensures timely release of products in compliance with established standards.
8. Assist in the QA release process, ensuring products meet established quality standards before release for production.
9. Demonstrate proactive leadership through GMP regular audits, monitoring, and enhancing the efficiency and effectiveness of QA release procedures.
10. Review/approve documents as a Quality Subject Matter Expert (SME).
11. Develop and uphold Standard Operating Procedures (SOP) and protocols, ensuring they align with quality practices and meet regulatory requirements.
12. Review batch records for accuracy and completeness for product disposition. Ensure that corrections are made in a timely manner. 
13. Apply a working knowledge of statistical based sampling plans. 
14. Write reports and provide information needed to investigate, document and close deviation.

QUALIFICATIONS

To perform this job, the individual must have FDA 21Part210/211 knowledge. Quality inspection experience in component or final product inspection is required.

Experience in a pharmaceutical environment is required (3 years minimum)

Self-motivated and proactive in preparing documentation and testing products.

EDUCATION AND EXPERIENCE

Knowledge of quality assurance in the drug industry with emphasis on contract manufacture requirements. Must have experience in inspection techniques, knowledge of batch records, certificates of compliance and assurance. Must pay attention to detail and perform inspections according to defined specification.

Understand computer entry of meta data for setting up workflows in SAP.

Familiar with Trackwise System

RESPONSIBILITY FOR FUNDS, PROPERTY and EQUIPMENT

None.

COMMUNICATION SKILLS

Ability to read and understand simple instructions, short correspondence, notes, letters and memos; Ability to write simple correspondence. Must be able to verbally and write comprehensive communications.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts such as fractions, ratios, and proportions to practical situations.

CRITICAL THINKING SKILLS

Ability to utilize common sense understanding in order to carry out written, oral or diagrammed instructions. Ability to deal with problems involving several known variables in situations of a routine nature.

SUPERVISION RECEIVED

Under general supervision where standard practice enables the employee to proceed alone on routine work, referring all questionable cases to manager.

Requirements:

• Valid driver’s license and acceptable driving record
• Legally authorized to be employed in the United States (U.S. citizens or national, permanent residents)
• Must live or willing to move to Sacramento Metropolitan Region (Approx. 40 miles’ radius)
• Able to successfully complete a drug and background check
• Able and willing to walk, stoop, stand, bend, and lift throughout each shift, with or without accommodation

Benefits:

• Pay range (Based on Experience)
• Yearly bonus eligibility
• Benefits: Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage
• Paid time off plan
• 401k savings plan

Additional Information:

Nivagen to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.