Specialist, Quality Assurance IT/Automation Compliance
- Charlottesville, VA
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
The essential functions include, but are not limited to:
- The Specialist Quality Assurance IT will be responsible for the quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations.
- This includes involvement in quality-related activities for computerized systems which are required by our Manufacturing Division's Quality Manual or with potential for impact on product quality, patient safety or data integrity.
- The position will work closely with stakeholders and SME's from site operations, quality operations, IT, automation and engineering to provide evidence of quality oversight throughout the computer system lifecycle and facilitate continuous improvement.
- The Specialist QA IT must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
As part of the global Quality Assurance IT team and reporting to the Associate Director of Quality Assurance IT , the Specialist Quality Assurance IT will be responsible for:
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and our Manufacturing Division's IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure 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.
Minimum Education Requirements:
- Bachelor's Degree. Preferably Information Technology, Engineering or equivalent.
Requires Experience and Skills:
- Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
- Minimum two (2) years of experience in delivering validated IT solutions or an application support role.
- 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.
- Demonstrated working knowledge of the principles, theories and concepts of computerized system validation / compliance.
- Familiarity or 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 Competencies 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 regulated pharmaceutical manufacturing and/or laboratory environment (Quality or Compliance role in GMP environment desired)
- Understanding of applicable Laboratory and/ or Engineering Standards related to computerized systems development, implementation & Operations
- Business engagement skills, with ability to collaborate with both technical and non-technical roles
- Multi-lingual capabilities preferred
- Experience supporting regulatory inspections
- Excellent oral and written communication skills including persuading others and developing cross functional relationships
- 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
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are ...
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
What we look for ...
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.
No Travel Required
Flexible Work Arrangements:
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