Senior Specialist, Quality Systems and Compliance (QSIP) Job - United States
Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, 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.
One of the essential building blocks of Merck Manufacturing Division’s (MMD) Back to Basics (BtB) strategy is the Quality Systems Improvement Program (QSIP). This is a multi-year program to retool MMD’s Quality Management System and is critical to the successful execution of the BtB program. Positions to support the QSIP initiative are highly coveted within the Quality Organization because they represent the challenging opportunity to focus on improving business processes and compliance posture of the company while continuing to run the business.
This Senior Specialist position within the Harmonization team of the Analytical Standards (AS) 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 at Merck. In this role, your focus will be four-fold:
- Improve the compliance for release/stability tests and methods for all Merck products globally by executing a strategy for harmonizing release tests and specifications from Legacy, Outsourced, and acquired products into the AS system
- Reduce the cycle time for creation of new AS against the historical baseline using LEAN principles
- Play key role in licensure and launch of all new products by creating AS to support manufacture
- Lead integration of critical reagent qualification protocols into the AS system
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 biologics 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 Merck’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 testing of drug products and/or medical devices.
- Minimum 7 years’ experience in analytical laboratory testing methods.
- Hands on expereince 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:
- Advanced degree
- Experience in qualification of reference standards for small molecules or critical reagents for vaccines and biologics
- Experience with CMC and product filings and the ability to accurately interpret and apply regulatory expectations to the AS
- Experience in analytical techniques for analysis of biological products
- Familiarity with Project Management Programs and philosophies
- Fluency in multiple languages
- Experience using Trackwise for analytical change control
- Experience creating final specifications and methods for release of products or raw materials
- Ability to accurately interpret and apply expectations for global compendia
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. If you need an accommodation for the application process please email us at firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Regulatory Affairs Generic
Job Title:Sr. Spclst, Regulatory Affairs
Primary Location: NA-US-PA-West Point
Other Locations: NA-US-NJ-Whitehouse Station
Employee Status: Regular
Travel: Yes, 20 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
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