Highlights
Position: Supply Chain Specialist Location: Santa Monica, CA 90404 Duration: 12 Months Job Type:Temporary Assignment Work Type: Onsite Job Description: We are seeking a highly motivated individual to join our Global Supply Chain (GSC) organization as a Senior Supply Chain Specialist Change Control Owner in the GSC Business Operations team, reporting into the Senior Manager of Supply Chain. The Senior Specialist will work closely with the GSC organization to own and manage Supply Chain initiated change controls by our Global and Regional Supply Chain teams as well partner with other Technical Operations functions: Quality, Process Development, and Manufacturing.
Numbers & Facts
| Location | Santa Monica, CA |
| Industry | Computer/IT Services |
| Salary | $70–$76 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.
Position: Supply Chain Specialist
Location: Santa Monica, CA 90404
Duration: 12 Months
Job Type:Temporary Assignment
Work Type: Onsite
Job Description:
- We are seeking a highly motivated individual to join our Global Supply Chain (GSC) organization as a Senior Supply Chain Specialist Change Control Owner in the GSC Business Operations team, reporting into the Senior Manager of Supply Chain.
- The Senior Specialist will work closely with the GSC organization to own and manage Supply Chain initiated change controls by our Global and Regional Supply Chain teams as well partner with other Technical Operations functions: Quality, Process Development, and Manufacturing.
- These partnerships ensure that GSC owned change controls meet and/or exceed Quality Management System requirements, meet compliance requirements, and are implemented flawlessly per established timelines.
- To create a deep partnership with stakeholders across the corporation, as well as to foster continued professional growth, we would like the Senior Supply Chain Specialist to be based onsite at Kite's Global HQ in Santa Monica, CA or any other Kite site in the network.
Responsibilities of the Senior Supply Chain Specialist Change Control Owner include:
- Leverages previous applicable experience to become Global Supply Chain's subject matter expert on Kite's QMS Change Control Management SOPs and application.
- Owns GSC initiated change control records and partner with Supply Chain SMEs to define, plan, and implement change control records across all global regions.
- Maintains record compliance by utilizing effective administration and communication resources and/or methods to track quality records for adherence to key record dates and gain approval for any business justified extensions.
- Tracks completion of pre-implementation, implementation, and post-implementation tasks, communicating interdependencies
- Effectively communicates with team members and key stakeholders on a record's status, risks, and mitigation plans.
- Maintains change control tracking resource for monthly status reporting.
- Coordinates change control records' tasks such as scheduling and facilitating meetings with relevant stakeholders.
- Acts as the Change Control Management point of contact for GSC project managers to ensure change control related milestones and tasks are incorporated into project plans and delivered per schedule.
- Partners with Quality to ensure that all change control records are followed through per governing procedures and standards.
- Utilizes change management principles to champion change for effective adoption and post project sustainment of changes introduced.
- Tracks and timely escalates in case of delays / new risks identified for change control records.
- Identifies and actively participates in the development and refinement of continuous improvement opportunities within Change Control and the broader Global Supply Chain.
- Additional responsibilities are expected as the role and functions remit evolve.
Basic Qualifications:
- Master's Degree with 3+ years of Supply Chain and/or Change Control and/or Operations experience(OR)
- Bachelor's Degree with 5+ years of the aforementioned experience(OR)
- Associate's Degree with 7+ years of the aforementioned experience(OR)
- High School Degree / GED with 9+ years of the aforementioned experience.
Preferred Qualifications:
- 1+ years' experience as a skilled practitioner in GMP Change Control and familiarity with QMS tools.
- 2+ years of relevant change control experience, preferably in a GxP environment.
- Proficiency in relevant technology such as Veeva QMS, Oracle Agile QMS, Trackwise, Smartsheet, MS Project, Visio, PowerPoint and MS Office for efficient project administration and implementation.
- Experience in life sciences industry such as cell/gene therapy, pharmaceutical, biotech, or medical devices is a plus.
- Demonstrated mastery of change control management processes, procedures and methodology.
- Independently motivated and detail oriented with excellent communication skills.
- Excellent organizational skills and ability to multi-task in a exciting environment.
- Collaborative individual, able to influence without authority and engage senior leaders and functional partners proactively.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.