- Multiple label artwork change projects in flight
- Supply continuity planning for 2nd source labels (procurement, design, test)
- Labeling deviation support
- MFG operations process improvements
- Label lifecycle improvements
- Product launch support (in house and outsource products)
- Education: Bachelor’s degree in Engineering, regulatory affairs, or a related field.
- Experience: Minimum of 5 years of experience in pharmaceutical packaging and labeling, with specific expertise in sterile injectables and medical devices.
- Regulatory Knowledge: Deep understanding of cGMP, FDA, EMA, and USP guidelines relevant to packaging and labeling, and experience filing label artwork changes.
- Technical Skills: Proficiency with quality systems including change control and quality events, proficiency in labeling equipment, label artwork review and compliance.
- Project Management: Demonstrated success in managing multiple projects in parallel.
- Communication and Collaboration: Excellent communication skills with the ability to work effectively across departments and influence stakeholders.
salary: $50 - $70 per hour
shift: First
work hours: 8 AM - 5 PM
education: Bachelors
Responsibilities
Packaging and Labeling Quality Specialist
Skilled in maintaining and enhancing packaging and labeling quality systems to comply with FDA, EMA, and related regulations. Develop and improve SOPs, work instructions, and quality documentation focused on lifecycle management.
Change Management:
Lead label change requests (LCR) and implement strategies to support product lifecycle changes, ensuring accuracy and compliance. Collaborate with cross-functional teams to evaluate and execute changes while minimizing operational impact.
Project Management:
Plan and execute packaging and labeling projects aligned with product launch timelines and regulatory requirements. Develop project scopes, timelines, and risk mitigation strategies to ensure seamless coordination and compliance.
Process Improvement:
Analyze workflows to identify process improvements, driving initiatives that enhance efficiency, compliance, and cost-effectiveness.
Technical Support:
Provide expertise for packaging and labeling issues, conduct root cause analysis, and implement corrective actions. Support manufacturing labeling operations and improvement projects.
Cross-Functional Collaboration:
Act as a liaison between quality, regulatory, and manufacturing teams to align labeling strategies with business objectives, ensuring timely and compliant product launches.
Skills
Qualifications
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Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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