Job Description

　　Position Description:

　　The Specialist - Quality Control, within Laboratory Operations, under the broad direction from the Associate Director – Quality Control (Equipment Support), will be responsible for the implementation and management of laboratory equipment and automated systems utilized within assigned laboratories.

　　The incumbent assures operation in accordance with our Manufacturing Division and Company safety policies and procedures, current Good Manufacturing Practices (cGMP) regulations, and within the departmental budget.

　　Responsibilities can include providing technical expertise and recommendations on Company, Divisional and Organizational projects such as capital requests, operational improvements, instrument repair, and run the business activities in support of all testing conducted within Laboratory Operations (LO).

　　Responsibilities:

　　Provides technical support as needed to other testing sites within our Company's network including partnerships with sites in Durham, NC and Haarlem, NL to help ensure operational alignment of test methods and equipment including support for analytical method transfers.

　　Support capital projects and coordinate equipment projects for assigned area within Laboratory Operations.

　　Works directly with the Equipment, Maintenance and Utilities team to prioritize and schedule preventative and corrective maintenance.

　　Assists in contract negotiations with associated vendor relations.

　　Initiates and participates in equipment related investigations and quality notifications to ensure compliance with current Good Manufacturing Practices (cGMP) and regulatory requirements to support the quality, safety, efficacy, and potency of our Company's products.

　　Position Qualifications :

　　Education Minimum Requirement:

　　BS/BA or M.S in Biology, Biochemistry, Chemistry, Engineering, Microbiology, Virology or other associated field with a minimum of 1 year of relevant laboratory, manufacturing, biotechnology or quality control experience.Required Experience and Skills:

　　Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills, and ability to work in a team environment.

　　Individual and team experience in a Quality or Manufacturing function.

　　Demonstrated technical expertise in analytical testing methodology, equipment and software validation principles, as well as a general understanding of the operation and mapping of controlled temperature units.

　　Preferred Experience and Skills:

　　Proven analytical aptitude, critical thinking skills, and ability to apply key concepts.

　　Speaks with courage and candor.

　　Strong written and verbal communication skills.

　　In-depth working knowledge and application of GMPs/GLPs.

　　Ability to manage multiple projects simultaneously.

　　Equipment management experience including qualification, calibration, preventative and corrective maintenance, System Development Life Cycle (SDLC), etc.

　　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.

　　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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.htmld)

　　Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

　　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 (https://survey.sogosurvey.com/r/aCdfqL) 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:

　　EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

　　EEOC GINA Supplement​

　　Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

　　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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

　　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:

　　No Travel Required

　　Flexible Work Arrangements:

　　On-Site

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　N/A

　　Requisition ID: R276580