Job DescriptionSummary, Focus and Purpose- The QC Data Services Specialist is responsible for stability laboratory data review, plant site release, review of site APR, data trending, and support of Quality Notifications and CAPAs.
- They demonstrate mastery of all data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.).
- Maintains positive site relations and supports other company divisions and third-party manufacturing and packaging sites.
- Assures compliance with FDA & GMP regulations.
- Demonstrates the ability to influence a team (including Global Support and Outside Organizations) and is a recognized resource to others.
Key FunctionsDevelopment- Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
- Participate in development of objectives and ensure alignment with site goals
Laboratory Support- Initiating/leading problem solving to identify short-term and long-term actions to prevent problem reoccurrence, reduce laboratory downtime and increase reliability
- Following standard work for escalation as it relates to safety and quality events
- Timely approval of qualification, change control, procedures and other documents
- Demonstrates a deep understanding of customer needs, requirements, and expectations
- Performs stability and plant site release and study approvals
- Supports GLIMS updates; reviews builds, IPI specification verification
- Review of technical memos and testing protocols
Information Transfer- Attends departmental and team meetings focused on Stability data review and reporting
- Serves as liaison between NASU teams, Leadership, and External Entities
- Ability to interpret our Company Quality Policies and Guidelines for daily application.
- Participates and/or Directs Tier Meetings
- Promotes teamwork and open discussion of issues.
- Statistical summary analysis for manufacturing site Annual Product Reviews (APR)
Education Requirements: - Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with 6gt;= 2 years in a pharmaceutical laboratory setting
Required Experience and Skills: - Prior experience in a pharmaceutical laboratory setting.
- Knowledge and experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)
Required Skills: Adaptability, Analytical Instrumentation, Analytical Method Development, Dissolution Testing, Driving Continuous Improvement, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment
Preferred Skills: Current Employees apply HERE
Current Contingent Workers apply HERE
The salary range for this role is
$87,300.00 - $137,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
na
Job Posting End Date:
09/5/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
