Specialist, Data Services (Stability)

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 NASU Stability program management, stability plan maintenance, coordination of monthly stability pulls and delivery, and support of stability related change controls, Quality Notifications and CAPAs. They demonstrate proficiency with all stability management and documentation programs (GLIMS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other company's and third-party manufacturing and packaging sites. Assures compliance with FDA & GMP regulations.

Key Functions

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Participate in development of objectives and ensures alignment with site goals

Development

• Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
• Participate in development of objectives and ensures 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 related 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
• Coordinates stability sample pulls and delivery to labs per defined scheduled intervals
• Set up international shipments for product to our sites
• Support stability chamber audits, excursions, and improvement initiates

Information Transfer

• Attends departmental and team meetings focused on Stability program
• 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.
• Metrics review and reporting to Quality Council, etc.
• Generates/maintains stability technical agreements with other sites in network

Compliance

• Uses Root Cause Analysis tools to identify true root cause for quality and safety events
• Authors, reviews, approves and/or participates in quality investigations
• Participates in internal and external audits and inspections
• Identifies product-related data trends and facilitates implementation of corrective actions
• Creates/Revises Standard Operating Procedures, Forms and other documents
• Understands and applies regulatory / compliance requirements, including GMP, NDA, and related regulations, and can interpret those regulations for implementation in the workplace.

Minimum Requirements

• Associate degree, preferably in Science with 4 years in a pharmaceutical laboratory setting
• Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with 2 years in a pharmaceutical laboratory setting

Preferred Experience and Skills

• Ability to quickly learn new processes and procedures.
• Experience working within a pharmaceutical Stability program.
• Experience working with multiple sites and/or third-party vendors.
• Working knowledge of GMP's, Government regulations.
• Good technical writing skills.
• Some experience in audit scenarios.

Current Employees apply HERE

Current Contingent Workers apply HERE

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. Please click here if you need an accommodation during the application or hiring process.

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.

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is
$85,600.00 - $134,800.00

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. 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 ;br>
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Animal Vaccination, Business, Dissolution Testing, Driving Continuous Improvement, Escalation Management, GMP Compliance, Karl Fischer Titrations, Laboratory Documentation, Laboratory Safety, Maintenance Planning, Maintenance Planning Software, Management Process, Microbiological Analysis, Microbiological Test, Motivation Management, Operation Maintenance, Problem Solving, Quality Management, Social Collaboration, Strategic Initiative, Strategic Planning {+ 5 more}

Preferred Skills:

Job Posting End Date:
07/22/2025
*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.