Senior Specialist, Quality Management Systems - United States
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- Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
- Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.
- To this end, we strive to create an environment of mutual respect, encouragement and teamwork.
- As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
- This Senior Specialist position within the Analytical Standards group is looking for an ambitious, process improvement enthusiast with Product Release Testing and Change Control Experience help us define the future of analytical change control on the Harmonization team in the Analytical Standards (AS) group.
In this role, your focus will include:
- Improve the compliance for release/stability tests and methods for all products globally by executing a strategy for harmonizing release tests and specifications from Legacy, Outsourced, and acquired products into the AS system
- Support license and launch of all new products by creating AS to support manufacture
- To be successful in this role, which works with a diverse slate of customers across organizations globally, both strong technical skills and interpersonal skills are critical. Therefore, you should possess the following traits:
- A strong analytical background with small molecule, vaccines, raw materials, or biologic experience
- The ability to proactively recognize and mitigate barriers to cross-functional initiatives and act as an intermediary across divisional, geographical, and cultural boundaries
- Promote a culture of continuous improvement and respectfully challenging the status quo, while driving departmental/regional strategies that align with company’s long term strategy
- Build trust and develop new relationships with internal and external clients to effectively collaborate and achieve successful outcomes at a regional/global level.
- Education Minimum Requirement:
- Bachelor’s Degree in a science or engineering discipline or related field
Required Experience and Skills:
- Thorough understanding of regulatory requirements for drug products and/or medical devices.
- Minimum 7 years experience in analytical laboratory for release testing or drug development.
- Use of the Trackwise Program for change control.
- Hands on experience running a variety of analytical methods, which would include two or more of the following: HPLC, densitometry, dissolutions, particle sizing, gel electrophoresis, spectrophotometric assays, immunoassays, cell based assays.
Preferred Experience and Skills:
- Ability to accurately interpret and apply expectations for global compendia
- Experience with CMC and product filings and the ability to accurately interpret and apply regulatory expectations to the AS.
- Previous experience creating AS as part of a product development team or commercialization team.
- Our employees are the key to our company’s success.
- We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.
- Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. Our company is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Travel: Yes, 20 % of the Time
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