Senior Specialist, QA IT/Automation Compliance

Date: May 16, 2019

Location: Durham, NC, US

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Requisition ID: QUA008950

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. 

As part of the global QA IT team and reporting to the Associate Director of QA IT or higher, the Sr. Specialist QA IT will be responsible for:

  • Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owners and Technical Unit) to assess and select computerized systems which enable GMP business processes. This includes:
o Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
o Interfacing with MMD IT and other internal & external entities to align GMP shop-floor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives

o Ensuring the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work.

  • Providing the independent quality approval of key qualification /validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations).
  • Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans).
  • Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective.
  • Supporting regulatory inspection and audit activities as needed. This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance.
  • Driving resolution of regulatory non-conformance for GMP computerized systems.
  • Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
  • Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices.
  • Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues.
  • Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems.
  • Mentoring, training and developing QA IT Specialist.



 Education Minimum Requirement: 

  • Bachelor's degree. Preferably in Science, Information Technology, Engineering or equivalent.
Required Experience and Skills:
  • Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
  • Min 5 years of experience in regulated pharmaceutical manufacturing industry.
  • At least 3 years of experience in delivering validated IT solutions or an application support role in a regulated environment.
  • Strong understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211, and 820 and local regulatory expectations.
  • Must demonstrate extensive knowledge of the principles, theories and concepts of computerized system validation / compliance.
  • Familiarity and practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
  • Limited supervision required in day-to-day activities.
Preferred Experience and Skills:
  • Professional Certifications (e.g. Six Sigma or certification in Project Management (PMP)
  • Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
  • Good understanding of applicable Engineering and/or Laboratory or Standards related to computerized systems development, implementation & Operations
  • Hands on experience in a Quality and/or Compliance role in a GMP environment
  • Business engagement skills, with ability to collaborate with both technical and non-technical roles.
  • Multi-lingual capabilities preferred
  • Experience in leading conversation during regulatory inspections
  • Excellent oral and written communication skills including persuading others and developing cross functional relationships both at site and across sites
  • Analytical Problem solving skills applied to issue identification and resolution
  • Listening, integrating diverse perspectives, adds value to the achievement of team goals
  • Timely decision making
  • Project management skills combined with a since of urgency and a proven history producing quality deliverables.
  • Ability to respond to changing priorities
  • Inclusion behaviors
  • Coach and develop others

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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Visa sponsorship is not available for this position.


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Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: None
Company Trade Name: Merck

Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

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