Quality Control Specialist

Merck; North Carolina; On-site; USD 85,000 - 110,000; Full time

Job summary

Merck in North Carolina seeks a QC Data Services Specialist in Quality Control to manage stability data review, plant site releases, APR reviews, data trending, and support of Quality Notifications and CAPAs.

The role requires mastery of data management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.) and maintaining positive site relations while supporting other divisions and third-party manufacturing sites. FDA & GMP compliance is essential.

Qualifications

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

Responsibilities

• Stability data review and plant site release.
• Review of site APR (Annual Product Review).
• Data trending and support of Quality Notifications and CAPAs.
• Mastery of data management and documentation systems (GLIMS, MEDS, IPI, SAP).
• Maintain positive site relations and support other divisions and third-party sites.
• Ensure compliance with FDA and GMP regulations.

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

Education

Bachelor of Science in Chemistry, Biology, or Engineering (≥2 years in pharma lab)

Tools

GLIMS

MEDS

IPI

SAP

Job description

Position Responsibilities:

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

Summary, 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 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)

Education Requirements

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 Fisher Titrations, Laboratory Documentation, Laboratory Safety, Microbiological Analysis, Microbiological Test, Teamwork, Technical Writing, Troubleshooting, Use of Laboratory Equipment

US and Puerto Rico Residents Only:

Equality and Inclusion Statement

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement

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