Merck & Co Hiring for Specialist, Digital & Data Quality job in Wilson Full Time

Job Description

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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

The Specialist, Digital and Data Quality will be responsible for the quality aspects of GMP computerized systems and the 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 all quality-related activities for computerized systems which are required by our Manufacturing Division 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 DDQ must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

Primary Activities include, but are not limited to:

As part of the Global Digital & Data Quality team, the Specialist collaborates with stakeholders (e.g., System Owners, Process Owners, Data Owners, Business Unit, Technical Units and Subject Matter Experts) to assess and remediate legacy systems and evaluate/implement new computerized systems, which enable GxP business processes. This includes:-

• Ensuring Technologies selected meet the high-level business needs while encouraging innovation and efficiency.
• Interfacing with Corporate Global IT and other internal & external entities to align GxP shopfloor, laboratory, quality system and/or infrastructure technology capabilities/solutions with quality policies and objectives.
• Assisting 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, specifications, 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 at-site/above-site system owners have Operating Level Procedures/Plans in place, and are routinely followed to ensure that 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 (including sufficiently detailed electronic data review/audit trail review instructions for users), 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 site) and taking appropriate actions to ensure GxP compliance.
• Driving resolution of regulatory non-conformance for GxP computerized systems.
• Assuring monitoring of system health, compliance and other metrics are communicated to key stakeholders.-
• Promoting GxP 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.
• Contributing to the development and/or maintenance of training programs in the principles of computerized systems validation, computer software assurance, and regulatory requirements in validation, data integrity, ALCOA principles, maintenance, and use of computerized systems.
• Providing Quality Unit review/approval of SDLC documentation

Required Education:

• Bachelor’s degree.- Preferably Information Technology, Engineering or equivalent.

Required Experience:

• Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations.
• At least two(2) years of experience in delivering validated IT solutions or an application support role.
• Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in Data Integrity, 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations.
• Must demonstrate 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)
• Good 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

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.

Residents of Colorado

Click here to request this role’s pay range.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). -Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. – All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. – For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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Pay Transparency Nondiscrimination

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’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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, generally Tuesday, Wednesday and either Monday or 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 presence. -This 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”.

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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st – Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Requisition ID:R285468