Everyone at Kite is grounded by one common goal – curing cancer. Every single day, we seek to establish a direct line between that purpose and our day-to-day work. Would you like to join us in this mission?
We are seeking a highly motivated, detail oriented and organized individual to join us as a Packaging Specialist. The Specialist, internally known as a Supply Chain Specialist II, will directly and indirectly manage all packaging-related Quality records including Change Control, Deviation, Product Compliant, CAPA, and Effectiveness Verification. Further, the incumbent will directly and indirectly lead the creation, implementation and compliance of all Packaging Engineering team documentation, procedures and policies. This role will report to the Associate Director of Packaging Engineering in Santa Monica, CA, with a dotted line to the Senior Packaging Engineer II in Amsterdam.
While the Packaging Specialist can be remotely-based anywhere within the contiguous United States, standard working hours for this opportunity will be Monday through Friday, 8am to 5pm EST (5am to 2pm PST).
Responsibilities of the Packaging Specialist include:
Investigates complaints/deviations and develops solutions (CAPAs) for issues related to logistics, packaging (materials and design), labeling, and cold chain transport
Provides support for lifecycle management of cold chain packaging and labeling components and processes by performing impact assessments and risk assessments
Collaborates with a cross-functional team to reduce quality record cycle times
Drives purchasing activities for packaging materials purchased under non-GMP POs
Develops reports and dashboards to monitor performance against metrics and KPIs
Provides periodic reports to Packaging Engineering management on progress and challenges
Ensures development, implementation and maintenance of appropriate training curricula
Complies with the company change control procedures to ensure that only approved packaging materials and processes are used
Works closely with internal partners, Materials Management, Quality, and Manufacturing to provide packaging and labeling solutions
Basic Qualifications:
Bachelor’s Degree
OR
Associates degree and 2+ years of teaching and/or writing and/or manufacturing and/or operations experience
OR
High School Degree with 3+ years of teaching and/or writing and/or manufacturing and/or operations experience
Preferred Qualifications:
Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment as this role will have multiple contacts across internal and external groups
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Proficient in MS word, Excel, PowerPoint, Project and Outlook
Working knowledge and understanding of GMP, GCP, GDP, and relevant ICH and FDA guidelines preferred but not required
Exceptional project management and organizational skills
Process-oriented with strong analytical skills for risk identification and management
Knowledge of supply chain operations preferred but not required
Cold chain knowledge and experience in a pharmaceutical or medical setting preferred but not required
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Experience with Oracle EBS and/or SAP preferred but not required
Does this sound like you? If so, please apply today!
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Colorado Job Applicants: The salary range for this position is:
$60,240.00 – $90,360.00
Kite considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
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