Growth and Improvement-minded Data Services Specialist

• We are seeking a Growth and Improvement-minded Data Services Specialist in Quality Control 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 Us, * 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 Functions

Development

• 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)

Biology Oncology Teamwork Chemistry Leadership Innovation Compassion Reliability Adaptability Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control Data Management SAP Applications Telephone Skills Technical Writing Laboratory Safety Analytical Method Influencing Skills Motivational Skills Contingent Workforce Packaging And Labeling Microbiological Testing Good Manufacturing Practices Continuous Improvement Process Troubleshooting (Problem Solving) Corrective And Preventive Action (CAPA), * Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with 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, Teamwork Chemistry Leadership Innovation Compassion Reliability Adaptability Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control Data Management SAP Applications Telephone Skills Technical Writing Laboratory Safety Analytical Method Influencing Skills Motivational Skills Contingent Workforce Packaging And Labeling Microbiological Testing Good Manufacturing Practices Continuous Improvement Process Troubleshooting (Problem Solving) Corrective And Preventive Action (CAPA) +0 Quality Control Specialist Merck & Co., Inc

Wilson, NC*On-Site

Memos Biology Oncology Teamwork Chemistry Leadership Innovation Compassion Reliability Adaptability Animal Health Change Control Prioritization Pharmaceuticals Problem Solving Quality Control Data Management SAP Applications Telephone Skills Technical Writing Laboratory Safety Analytical Method Influencing Skills Motivational Skills Contingent Workforce Packaging And Labeling Microbiological Testing Good Manufacturing Practices Continuous Improvement Process Troubleshooting (Problem Solving) Corrective And Preventive Action (CAPA)

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $87,300.00 - $137,400.00

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 in place, introductions are position specific. Please, no phone calls or emails.