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 companys 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 otherdocuments

• 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 GMPs Government regulations.

• Good technical writing skills.

• Some experience in audit scenarios.

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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 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:

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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 anothers 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 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

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 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

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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.

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