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:

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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:

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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.

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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:
Regular

Relocation:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
12/25/2024
*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:R318140