Stability Sample Management Specialist

3 weeks ago

Rahway, United States Merck Sharp & Dohme Full time

We are seeking a Growth and Improvement minded Stability Sample Management Specialist | Analytical Chemistry that can help drive our Strategic Operating Priorities.
- Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
- Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
- Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
- Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
- Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success - They are a Competitive Advantage for

**Summary, Focus and Purpose**

The Analytical Chemistry in Commercialization and Supply (ACDS) Operations and Compliance group has an exciting opportunity for Stability Sample Management Specialist. We are searching a highly talented and motivated individual to serve in a stability sample management specialist role that is responsible for the oversight of stability chambers and all associated sample management activities in a fast-paced, multidisciplinary lab environment.

**Key Functions**
- Liaising with source areas to coordinate setup of new stability studies according to protocols | Load stability protocols in LIMS and coordinate approval of LIMS stability protocols
- Conduct routine sample pulls from stability chambers according to established procedures, prepare samples for shipments to multiple testing laboratories and process samples for destruction
- Ensure stability chambers are qualified, calibrated, and maintained
- Oversee and/or support change management related to stability chamber repairs or lifecycle management
- Oversee regular housekeeping inspections as well as routine cleaning of stability chambers
- Participate in re-engineering of stability processes and continuous improvement efforts
- Coordinate overseas shipments and configure temperature monitoring devices

**Education**
- B.S. Degree in Chemistry or closely related scientific field

**Experience | Skills | Knowledge**

**Required**
- Experience working within a regulated (GMP) environment
- Proficiency with MS Office (Word, Excel, Powerpoint, Access)
- Ability to work in a fast paced, dynamic GMP, regulatory environment
- Customer service oriented, multiple functional area requestors
- Experience in stability/chamber environment
- Strong written and verbal communication and attention to detail skills
- Capable of working both independently and within a cross-functional team to deliver complex objectives under aggressive timelines in a rapidly changing environment.
- Strong interpersonal skills for interacting with a variety of on-site and off-site collaborators and partner groups

**Preferred**
- Experience in LIMS and electronic notebook
- Familiarity with authoring relevant instrument standard operating procedures (SOPs)
- Experience in internal/external quality inspections and audits
- Experience with change management and deviation management

**NOTICE** **FOR** **INTERNAL** **APPLICANTS**

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

**Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.**

**US and P

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