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Knowledge of biomarker strategy and digital health technologies a strong plus. Excellent written and communication skills with attention to detail; highly computer literate (Word, Excel PowerPoint, SharePoint), including formatting documents for regulatory submission; experience with Veeva preferred.
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Experience with Veeva (Quality Docs, QMS and Training modules) a plus. Intermediate knowledge of Microsoft Word, Microsoft Excel and Adobe AcrobatKnowledge of cGMP/GDP regulations, ICH Guidelines, and CMC (Chemistry and Manufacturing Controls) recommendedExcellent communication, organizational, interpersonal and computer skillsExcellent Oral/Written Communication SkillsDemonstrated ability to manage multiple competing prioritiesSolid organizational skills and attention to detail.
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Continuous Improvement Initiatives: Leading or participating in continuous improvement initiatives to enhance the effectiveness and efficiency of quality systems and processes, driving a culture of quality and excellence within the organization.
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Ability to process information quickly and correctly while maintaining a high level of customer service and communication. Global Pharmaceutical company, with US HQ in Central New Jersey, focused in Metabolics, Endocrinology and Oncology is expandingLooking for a strong Quality Assurance Manager for the entire North American manufacturing and quality organization.
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Position requires on-site presence at companies' HQ Essential Duties and Responsibilities Conducting Training: Developing and conducting training programs for personnel on GMP and GDP requirements, quality systems, and relevant procedures to ensure understanding and compliance throughout the organization.
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Sets and manages audit schedule – collaborating with Tech Ops and internal QA to ensure audit reporting reflects current state of compliance at COs and to help address issues requiring remediation.
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Quality Risk Management: Implementing quality risk management processes to identify, assess, and mitigate risks to product quality, patient safety, and regulatory compliance throughout the product lifecycle.
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Managing Supplier and Vendor Quality: Assessing and approving suppliers and vendors based on their adherence to GMP and GDP standards. Reviewing and Approving Documentation: Manage the document lifecycle of Standard Operating Procedures (SOPs) and contribute to procedural changes as needed to meet GMP, corporate and regulatory requirements.
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Candidates should have excellent academic background plus reading, writing, communication and attention to detail skills. The salary ranges from $105,000 to $115,000 plus benefits (health insurance, 401(k), life insurance, CLEs, registration fees, etc.
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Required) Ability to communicate and read labels in English (Spanish a plus). Must have previous experience cleaning manufacturing equipment (required, no exceptions) Attention to detail Physical stamina Schedule : 1st shift (ONLY) Monday-Friday Pay rate: Up to $18/hr.
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