Nivagen Pharmaceuticals, Inc.
Label Control and Packaging Supervisor
Sacramento, CA 95834
Sponsorship not specified$75k-$90kDetected 21 days ago
SAPCustomer SupportGMPFDA RegulatoryLeadershipCommunicationCritical Thinking
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odds of building a lasting career here
39Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds (Level I)39
Fits your clock70
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About the role
- This position is responsible for supervising Nivagen label control and packaging area.
- 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.
Responsibilities
- 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.
- Manage the Packaging Component Specification program by obtaining documentation for components that have product contact from project managers, engineers, or purchasing.
- Create documentation for Quality inspection of each packaging component against supplier drawings, supporting documentation and physical testing.
- Maintain the initial and final documentation in the electronic management system.
- Maintain all working areas in a clean and orderly state. Assure products are stored, segregated and clearly labeled.
- 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.
- Develop quality inspection criteria for finished products to include label review, temperature requirements, and destructive testing for quality attributes, if applicable.
- Review/approve documents as a Quality Subject Matter Expert (SME).
- Develop and uphold Standard Operating Procedures (SOP) and protocols, ensuring they align with quality practices and meet regulatory requirements.
Requirements
- 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)
- Knowledge of quality assurance in the drug industry with emphasis on contract manufacturing requirements.
- Must have experience in inspection techniques, knowledge of batch records, certificates of compliance and assurance.
- Ability to read and understand simple instructions, short correspondence, notes, letters and memos
- Ability to write simple correspondence.
- Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
- To perform this job, the individual must have FDA 21Part210/211 knowledge. Quality inspection experience in component or final product inspection is required.
- Self-motivated and proactive in preparing documentation and testing products.
- Knowledge of quality assurance in the drug industry with emphasis on contract manufacturing 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 Track wise System
- RESPONSIBILITY FOR FUNDS, PROPERTY and EQUIPMENT
- Ability to write simple correspondence. Must be able to verbally and write comprehensive communications.
- 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.
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.
- Ability to apply concepts such as fractions, ratios, and proportions to practical situations.
- 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.
Compensation
- Pay range $75,000- $90,000
Benefits
- Yearly bonus eligibility
- Paid time off plan
- Nivagen offers a wide variety of benefits and programs to support health and well-being Medical, dental and vision coverage
Visa & Work Authorization
- iduals 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 s
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