Quality Control Specialist

Merck; Wilson (NC); On-site; USD 87,000 - 137,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

Retirement Benefits (401k)

Paid Holidays

Vacation

Sick Days

Job summary

Merck in the United States (North Carolina) seeks a Growth and Improvement-minded Data Services Specialist in Quality Control to support stability data review, site release, APR reviews, data trending and quality notifications.

You will master data management tools (GLIMS, MEDS, IPI, SAP), collaborate across sites, ensure FDA and GMP compliance, and influence teams to deliver reliable results for patients and customers.

Qualifications

• BS degree in chemistry, biology or engineering with pharma lab exposure.
• Minimum 2 years in a pharmaceutical laboratory setting.
• Experience with data management and documentation systems.

Responsibilities

• Stability data review and plant site release support.
• Review site APRs, data trending and CAPA/Quality Notifications.
• Maintain documentation across GLIMS, MEDS, IPI and SAP.
• Ensure compliance with FDA and GMP regulations.
• Collaborate across NASU and external partners to deliver quality data.

Skills

Data management

Analytical skills

Process improvement

Quality control

Education

Bachelor of Science in Chemistry or related field

2+ years pharma lab experience

Tools

GLIMS

MEDS

IPI

SAP

Job description

Job Description

• 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

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.

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.

Requirements

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 encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Salary

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.

Benefits

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.

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

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

• 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.

Requisition ID: R412671