Job Description

Our Technology Compliance team is seeking a passionate Associate Specialist to join our team and contribute to the growth.

They will engage IT product, engineering, and service teams to understand and implement technology and process controls to meet the company's policy and regulatory obligations.

They will identify and engage in remediation of IT compliance risks.

Also manage IT Compliance Processes and IT's enabling processes and services including System Development Life Cycle (SDLC), Corrective and Preventative Actions (CAPA), Personnel Qualification, IT Regulatory Control Services, Independent Compliance Monitoring including any supporting records and information.

Key Responsibilities:

• Assist in projects and programs:

• Consult project managers on risk-based compliance and validation during the project execution life cycle.

• Optimize processes:

• Harmonize and align global SDLC standards with local regulatory requirements in collaboration with the QA units.

• Consult and Advise:

• Advise business and IT on IT validation requirements and processes.

• Advise the team in archiving of electronic records including country specific GxP requirements.

• Support Operational processes

• Verify that service management processes (Change management, Incident, Problem) are conducted compliant to the established risk of the system together with our maintenance team.

• Drive specific operational processes

• Periodic Review for regulated systems

• User Access reviews

Education:

• High school diploma or equivalent.

Required Experience and Skills:

• Minimum 1 years of relevant experience

• Expert understanding of GxP on computerized systems.

• Experience in implementation in regulated environments following GLP, GMP, 21 CFR Part11, animal welfare law requirements and other compliance related regulation.

• Experience with regulatory inspections.

• A demonstrated track record of success as an IT validation specialist.

• Experience with an IT validation framework.

• Effective at working with business partners and IT colleagues.

• Strong delivery skills.

• Can work with many different personalities.

• Strong personal and professional ethical values, impeccable integrity

Preferred Experience and Skills:

• Validate Computerized Systems (Lab Systems & Lab platforms) using the company standard SDLC, Animal Health R&D and local / regulatory requirements.

• Guide documentation through the required processes in the document management platforms

MSJR

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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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, Monday - 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".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

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Requisition ID:R317785