Job Description
Position Responsibilities:
We are seeking a Growth and Improvement minded Data Services Senior 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 Senior 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 mastery of all stability management and documentation programs (GLIMS, SDS, MEDS, IPI, SAP, etc.). Maintains positive site relations and supports other our company 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 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
Acts as a QMS topic lead for Topic 5.3 "Expiration, Retest Dating and Stability"
Conduct annual profit planning for NASU
Manage quotes and POs for external laboratory testing
Set up international shipments for product to our company 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.
Stability Demand Sharepoint (SDS) oversight and NASU Site Master List maintenance
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 7 years in a pharmaceutical laboratory setting
Bachelor of Science degree, preferably in Chemistry, Biology, or Engineering with 5 years in a pharmaceutical laboratory setting
Master of Science degree, preferably in Chemistry, Biology, or Engineering with 3 years in a pharmaceutical laboratory setting
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.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
Pay Transparency Nondiscrimination
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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".
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:
RegularRelocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
1st - DayValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
12/25/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe 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:R318140