Quality Control Specialist

Biopharma Careers

Kansas

On-site

USD 87,000 - 137,000

Full time

8 days ago

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Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401(k) retirement plan

Paid holidays

Vacation

Job summary

Merck & Co. is seeking a QC Data Services Specialist focused on growth and improvements in Quality Control. You will master data management tools and lead stability data review, site release activities, and CAPA support to ensure FDA and GMP compliance.

Collaborate with NASU, Global Support, and external sites to uphold high standards. The role emphasizes cross-functional teamwork, problem solving, and maintaining robust documentation using GLIMS, MEDS, IPI, and SAP.

Qualifications

Bachelor of Science degree in Chemistry, Biology, or Engineering with ≥ 2 years in a pharmaceutical laboratory setting.
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 reporting.
Support of Quality Notifications and CAPAs.

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/Engineering

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

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.

Equal Employment Opportunity

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.

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 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

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.