TEIC Associate at Keywords Studios

Indianapolis, Indiana, United States

Keywords Studios Logo
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceutical, Clinical ResearchIndustries

Requirements

  • Prefer Experience with Distribution – preferably Clinical Trial, Clinical Research, Distribution or Supply Chain
  • Strong attention to detail and accuracy
  • Ability to manage multiple priorities and meet timelines
  • Ability to build collaborative working relationships and work in a team environment
  • Good written and verbal communication skills in a multi-cultural settings
  • Ability to proactively identify and solve problems
  • Learning agility and self management skills
  • Ability to learn a variety of IT systems (e.g. CT Win/SAP)
  • Experience with Microsoft Office

Responsibilities

  • Manage the temperature excursions with exceptional customer focus to final material disposition (customers include CRAs and Investigator sites globally)
  • Respond to all Temperature Excursion submissions and communications swiftly, clearly and accurately (primarily via e-mail)
  • Collaborate with the Development Stability Group, Clinical Supply Coordinators, Global Distribution and others to provide Fit for Use disposition, resolve issues and ensure adequate supply is available at sites to avoid patient impact
  • Meet or exceed current cycle time expectations for each step of the process applicable to TEIC role
  • Monitor and escalate issues in a timely manner
  • Follow all procedures for determining material disposition and create clear documentation of all decisions to demonstrate a controlled process
  • Identify communication and/or process gaps and initiate solutions
  • Implement and monitor key measures and metrics to demonstrate compliance and process execution
  • Develop and implement methods to measure customer satisfaction
  • Create and develop tools to assist in supporting the effective execution of the process
  • Lead and ensure consistency in appropriate training materials and procedures are created, maintained, and governed
  • Assist in identifying the root causes of any process related issues, affecting, but not limited to compliance and quality
  • Contribute to interpreting the GxP Guidelines and other appropriate guidelines and regulations that affect the processes
  • Utilize the software application, Trackwise, for daily activities

Skills

deviation management
temperature excursions
customer communication
Trackwise
GxP compliance
root cause analysis
process improvement
clinical supply coordination
material disposition
metrics monitoring

Keywords Studios

Comprehensive service provider for video games

About Keywords Studios

Keywords Studios provides a wide range of services for the video games industry, supporting the entire lifecycle of game development. Their offerings include game-ready art, marketing, game development, functional and localization testing, text and audio localization, casting, audio post-production, community management, player support, and content moderation. The company utilizes proprietary technology to enhance its end-to-end platform, allowing clients to effectively bring their game concepts to life. Unlike many competitors, Keywords Studios focuses on delivering customized solutions that cater to the specific needs and budgets of their clients. The goal of Keywords Studios is to assist game developers and publishers in creating engaging digital content that entertains, connects, and educates players.

London, United KingdomHeadquarters
1998Year Founded
$487.8MTotal Funding
IPOCompany Stage
Consumer Software, Entertainment, GamingIndustries
5,001-10,000Employees

Benefits

Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Disability Insurance
Unlimited Paid Time Off
Paid Vacation
401(k) Company Match
401(k) Retirement Plan
Flexible Work Hours
Company Equity

Risks

Increased competition may impact Keywords Studios' market share in the gaming industry.
Integration of acquired companies could pose operational challenges and affect service quality.
Reliance on major clients like Microsoft may lead to revenue volatility.

Differentiation

Keywords Studios offers end-to-end services for the entire game development lifecycle.
The company has a global presence with over 13,000 professionals in 25+ countries.
Proprietary technology enhances Keywords Studios' platform for digital content creation.

Upsides

Acquisition of Certain Affinity expands Keywords Studios' AAA game development capabilities.
Integration with Microsoft's Community Sift boosts AI-enabled content moderation services.
Private equity interest indicates strong market confidence and strategic growth potential.

Land your dream remote job 3x faster with AI