Quality Specialist II

2 weeks ago


Fort Lauderdale, United States Unicon Pharma Inc Full time
Job DescriptionJob Description

Temp to Perm: Yes

Must Haves:

  • Bachelor’s degree (preferred), Associate Degree (required).
  • Must possess intermediate to proficient skillset in Excel when reviewing large data and general Microsoft Applications.
  • Written and oral communication skills via email and phone when presenting to internal and external stakeholders is a must.
  • Track record of strong communication, collaboration, and team-building skills; ability to connect with all levels of an organization. Ability to influence both internal and external stakeholders.

The goal is to build a fully electronic, interoperable system to identify and trace prescription drugs for distribution through the supply chain. Full track and trace will be achieved by:

  • Facilitating the electronic exchange of transaction information for each sale of prescription drugs.
  • Use and review product identifiers to verify products at the item level.
  • Improve the efficiency of recalls.
  • Support the development, implementation, and ongoing management of Drug Supply Chain Security Act (DSCSA) to maintain Compliance.

In this role, you will learn the interoperable system to set up and establish connections between Anda and its Trading Partners related to this exciting and trailblazing program.

AREAS OF RESPONSIBILITY:

  • Acquire in-depth knowledge of the TraceLink system and sub-modules (training will be provided).
  • Collaborate with various levels of management, cross-functional teams, and external stakeholders.
  • Highly organized with the ability to manage, track and escalate (as needed) multiple tasks and activities.
  • Conduct testing with vendors, customers and serialization providers to ensure successful connectivity.
  • Excellent written and oral communication skills is a must; individual will be working directly with Anda customers and vendors via email or phone to coordinate the onboarding into the TraceLink application.
  • Support end users with issues related to the TraceLink application, EPCIS file errors, and sub-modules.
  • Perform all activities in compliance with the internal and external requirements/standards controls.
  • Perform activities such as computer work, preparing, investigating, researching, and analyzing data.
  • Perform related duties as assigned and may cross-train to support other Compliance activities.

POSITION REQUIREMENTS:

Any equivalent combination of education, training, and experience that fulfills the position's requirements will be considered. Qualifications and Education:

  • Bachelor’s degree from an accredited college or university with (3) years of experience; or equivalent combination of education and related experience.
  • Full-time work experience related to pharmaceutical industry, supply chain management (distribution), regulatory affairs or equivalent education and experience.
  • Excellent communication, organizational, relationship management and analytical skills.
  • Diverse in utilizing variety of technical application systems (Salesforce, Tracelink, TPS, Cognos, Smartsheet, Microsoft Office, XML). Must possess intermediate to proficient skillset in Excel when reviewing large data.
  • Ability to muti-task, take initiative and prioritize in fast-paced Compliance environment to meet deadlines.
  • Good interpersonal and communication skills, with the ability to work independently and in collaborative team environment. Candidate must be able to strongly interact with all levels of organization and external audiences.

 

Company DescriptionWe focus exclusively on Life Sciences—Nothing Else.

From our inception, we’ve maintained a singular focus on working with Life Science companies and the industry’s leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We’ll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.Company DescriptionWe focus exclusively on Life Sciences—Nothing Else.\r
\r
From our inception, we’ve maintained a singular focus on working with Life Science companies and the industry’s leading businesses. We leverage our experienced, customer-facing team, vast network of 90,000+ Life Sciences professionals, and relationship-first approach to become your trusted advisor and empower you to achieve your goals and future jobs. We’ll work closely with you to listen to your needs, consult you on the most strategic solution, and partner with you to deliver that solution. So, contact us today, stop settling for subpar talent and instead partner with the industry experts and focus more on what you do best: growing your career in an effort to improve quality of life for communities around the world.

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