Senior Stability Associate

1100 Mylan Pharmaceuticals Inc.

Morgantown, Northern (WV, KY)

On-site

USD 39,000 - 88,000

Full time

5 days ago
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Job summary

Viatris is seeking an Associate Customer Relations, Contact Center to support stability study operations and compliance activities. This role handles GMP scale-up stability samples, maintains LIMS and Records Management System logs, and supports ANDA submissions.

Candidates should have 2–4 years of experience, knowledge of analytical testing processes, and strong written and verbal communication. The role is on-site in Morgantown, WV with competitive pay and an inclusive environment.

Qualifications

  • Minimum 2-4 years of experience in related roles.
  • Must understand analytical testing processes, SOPs, GxP, OSHA, and DEA regulations.
  • Must have good communication and interpersonal skills.
  • Ability to multi-task and follow detailed procedures.
  • Proficiency in reading, writing, and interpreting business documents.
  • English reading/writing/speaking proficiency required.

Responsibilities

  • Perform stability studies setup for GMP scale-up and experimental lots.
  • Conduct daily stability pulls for ANDA submissions.
  • Maintain inventory, labeling, tracking, and logging in LIMS for stability samples.
  • Maintain Records Management System documentation and file organization.
  • Order, release, audit and maintain Laboratory Workbooks.
  • Monitor chamber charts weekly and update as needed.
  • Support Training in R&D Operations Stability Rooms and File Rooms.
  • Perform other duties as assigned.

Skills

Communication skills
Multi-tasking
Written communication
Reading business documents
Interpersonal skills
Team collaboration

Tools

LIMS database
Records Management System

Job description

Mylan Pharmaceuticals Inc. Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Every day, we rise to the challenge to make a difference and here's how the Associate Customer Relations, Contact Center will make an impact:

Key responsibilities for this role include:
  • Perform set down of all stability studies for GMP scale up lots and experimental lots.
  • Perform daily sample stability pulls to support ANDA submissions.
  • Maintain all inventory, labeling, tracking, and logging within the LIMS database for scale-up and stability samples.
  • Maintain labeling, tracking, and logging within the Records Management System for appropriate documents and files.
  • Order, release, audit, and maintain Laboratory Workbooks.
  • Perform chamber chart monitoring including weekly changing of all charts in multiple locations.
  • Perform duties within the Research and Development Operations Stability Rooms and File Rooms, as needed.
  • Perform training for the Research and Development Operations Stability Rooms and File Rooms, as needed.
  • Perform other duties as assigned.
  • Intermittently sitting, standing, walking or stooping.
  • May be required to stand, walk, stoop, bend, kneel, and climb steps.
  • May require use of hands and use of arms.
  • Medium lifting requirements of 25-50 pounds.
  • Normal office and laboratory situation.
The minimum qualifications for this role are:
  • Minimum of 2-4 years of experience.
  • However, a combination of experience and/or education will be taken into consideration.
  • Must possess basic understanding of analytical testing processes, Standard Operating Procedures, Mylan Laboratory Procedures, health authority regulations, GxP, OSHA regulations, DEA regulations and procedures for safe handling of chemicals.
  • Must possess good communication and interpersonal skills.
  • Must be able to multi-task.
  • Position functions autonomously.
  • Ability to read and interpret general business documents.
  • Ability to write routine reports and general business correspondence.
  • Ability to work with peers and communicate basic concepts.
  • Ability to add, subtract, multiply, and divide; compute rations and percentages.
  • Ability to solve practical problems through standardized solutions that require limited judgment.
  • Ability to follow prescribed and detailed procedures to solve routine problems.
  • Proficiency in speaking, comprehending, reading and writing English is required.

Exact compensation may vary based on skills, experience, and location.

The salary range for this position is $39,000 - $88,000.

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, gender expression, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.

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