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Data Integrity Specialist

Requisition ID: QUA008275

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its¬ legacy for over a century. Merck's success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.¬ 


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The Data Integrity specialist is responsible for oversight of the implementation and communication of agency and MMD DI requirements within the Merck Elkton, VA manufacturing facility. The responsibilities of this role are to implement and maintain the DI Quality Management System, communicate pertinent DI information, support DI training, and promote a healthy Data Integrity culture. The role will require working closely with Quality, Technical Operations, and the Data Integrity Center of Excellence organizations at the global and local level to ensure regulatory compliance.



GENERAL RESPONSIBILITIES:




  • Works in an empowered, self-directed culture with independent decision making in the planning, coordination, and execution of multiple activities and projects.

  • Maintains an active dialog between affected departments and leadership to ensure project progress and milestone success.

  • Responsible for effective document review and conformance to Merck Manufacturing Standards, MMD Quality Policies, cGMPs for the generation and approval of the required documentation and testing.

  • Coordinate and perform assessments of new and existing systems and periodic inspections with remediation of existing systems.

  • Trains user community on the application of best practices and pertinent (Data Integrity and Systems Development Life Cycle) topics.

  • Develops, reviews and approves site procedures and review updates to divisional guidelines.

  • Responds to divisional initiatives and Quality Alerts.

  • Analyzes and solves problems using standard problem-solving processes.

  • Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.

  • Provides instructor-based training sessions to Merck personnel pertaining to Data Integrity requirements.

  • Creates and maintains quality based metrics to be shared to the Site Leadership Team.¬ 

  • Understands and applies regulatory/ compliance Data Integrity requirements



FUNCTIONAL EXPERTISE:



The Data Integrity Specialist will be responsible for activities that support regulatory and cGMP compliance programs and initiatives to include the following:




  • Support implementation of DI Global Procedures (document reviews, pilots, and implementation)

  • Supports site for DI Inspection Readiness/ Inspection Responses for DI

  • Assists with integration of Quality Risk Management as it relates to data governance and GMP records

  • Informed of and support to site investigations, as needed, related to Data Integrity.

  • Active participant in DI Knowledge Management Forum/ Community of Practice

  • Distribution of DI information within the site I functional area, and from the site/ functional area to the DI COE

  • May participate in external DI forum

  • Reviews and approves SOPs as appropriate.

  • Support operational excellence initiatives targeted to increase the speed, flexibility and efficiency of processes as appropriate

  • Performs special quality projects / investigations as requested by Senior Quality Management.

  • Other duties as requested by Quality management.






Qualifications

Education Minimum Requirement:




  • B.S./B.A. Degree is required. Engineering, Science, or Information Systems.



Required Experience and Skills:




  • A minimum of 2 years manufacturing and/or quality operation experience within an FDA and/or EU pharmaceutical, device or biologics environment.

  • Basic understanding of Data Integrity principles and requirements.

  • Familiarity with Quality systems including change control, incident management and deviation management.¬ 

  • Experience working with customers, understanding concerns and challenges, while applying regulatory compliance and company policy guidance and maintaining excellent relationships.¬ 

  • Ability to participate in highly effective teams in a matrix organization.

  • Ability to work with all levels of business customers in a highly dynamic environment to achieve shared objectives.

  • High personal integrity, credibility, and energy.



Preferred Experience and Skills:




  • Experience with automation systems for pharmaceutical, biological or bulk-manufacturing facilities is a plus.

  • Experience with, and in-depth understanding of, System Development Life Cycle (SDLC) is preferred.

  • Familiarity with automated data generating systems used within pharmaceutical manufacturing and laboratory environments.¬ 




Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we're counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we're inventing for life.¬ 

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If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to¬ staffingaadar@merck.com.


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Search Firm Representatives Please Read Carefully:¬ 


Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.¬  Please, no phone calls or emails.¬  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.¬  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


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Visa sponsorship is not available for this position.


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For more information about personal rights under Equal Employment Opportunity, visit:


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¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC Poster


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ EEOC GINA Supplement¬ 


¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬ ¬  OFCCP EEO Supplement


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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran ‚€“ proudly embracing diversity in all of it's manifestations.

Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: No
Company Trade Name: Merck

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