Quality Control Specialist

MSD•Wilson, NC

2d•$87,300 - $137,400•Onsite

About The Position

We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control that can help drive our Strategic Operating Priorities. 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.

Requirements

Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting
Prior experience in a pharmaceutical laboratory setting
Knowledge and experience with data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.)
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

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

Stability laboratory data review
Plant site release
Review of site APR
Data trending
Support of Quality Notifications and CAPAs
Demonstrates 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
Participate in development of objectives and ensure alignment with site goals
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
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)