Senior Stability Associate

Biopharma Careers; Morgantown (WV); On-site; USD 39,000 - 88,000; Full time

Job summary

Viatris is seeking an Associate Customer Relations, Contact Center in Morgantown, WV to support GMP stability operations and regulatory submissions.

You will perform stability studies for GMP scale-up, daily stability pulls for ANDA submissions, and maintain inventory and documentation in LIMS and Records Management System. Training and other duties may be assigned.

Qualifications

• Minimum 2–4 years of experience, or equivalent education.
• Knowledge of analytical testing processes, SOPs, GxP, health authority, OSHA and DEA regulations.
• Strong communication and interpersonal skills; able to multitask.
• Ability to read and write routine business documents in English.

Responsibilities

• 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 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.

Skills

Communication skills

Multi-tasking

Reading/writing English

Autonomy

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.

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.
• 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.
• 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.