Specialist, Digital and Data Quality Assurance As part of the Global Quality team the Specialist QA will be responsible for:

• Supporting QMS Topic Development for Master Data Management & Governance, Computer System Validation, Data Integrity Program including authorizing Global Standards, Procedures, Work Instructions, Job Aids, Training Material.
• Implementing and managing data governance policies and procedures to ensure data quality and compliance with internal standards.
• Managing systems to ensure quality, regulatory and GMP compliance expectations by
  • Ensuring that all tasks are performed in accordance with quality policies and procedures, satisfy the requirements of cGMP and are in accordance with the appropriate regulatory guidelines.
  • Interfacing with our Digital our Manufacturing Division and other internal & external entities to align with quality policies and objectives.
• Providing the independent quality approval of key qualification /validation documentations 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
• Ensuring that Quality Management System documents such as Deviations, Complaints, CAPA, Risk Assessments, and Change Control are raised and closed out promptly
• Support complex technical quality requirements in specific IT Infrastructure and CSV situations, such as validation of new systems, upgrades, changes, or remediation, etc.
• Become a primary point of contact for the business, providing advice/guidance on quality standards and expectations associated with Master Data.
• 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.
• Monitoring and communicating system health, compliance, and other metrics updates to key stakeholders.
• Drive continuous improvement to deliver efficiency and compliance gains. Periodically review quality systems and practices for improved efficiencies and to assure greater compliance.
• Contribute to the development and maintenance of training programs in the principles of master data management, computerized systems validation and regulatory requirements in validation, maintenance, and use of computerized systems.

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.
• Minimum 2 years of experience in regulated pharmaceutical manufacturing industry.
• Familiarity with Data standards, Data quality and Master Data Management.
• 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.
• 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.
• Good writing and communication skills

Preferred Experience and Skills:

• Operate as part of a self-directed team in carrying out day to day functions and assigning priorities.
• 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.
• 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 sense of urgency and a history of producing quality deliverables.
• Ability to respond to changing priorities.
• Inclusion behaviors.

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\xe2\x80\x99s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. Who we are \xe2\x80\xa6 We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world\'s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for \xe2\x80\xa6 Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us\xe2\x80\x94and start making your impact today. Current Employees apply HERE Current Contingent Workers apply HERE 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: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s): Job Posting End Date: 06/5/2024

• 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.
  

Job Posting End Date:06/05/2024
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:R294327