Job Description

　　The Laboratory Operations Quality Specialist provides quality oversight of the qualified utilities environmental monitoring data and systems at the West Point vaccine manufacturing site. The Specialist, with guidance from the Associate Director of Environmental Monitoring, ensures the qualified utilities (Water-for-Injection, Clean Steam, Compressed Gases) are being sampled as required and are operating in a state of environmental control. This position works closely with the vaccine manufacturing departments and Engineering/Maintenance to ensure timely completion of tasks with emphasis on right first time.

　　The specialist will become knowledgeable in regulatory requirements and cGMPs to assure the qualified utilities operate in a state of compliance and gain competency in their responsibilities. Specific responsibilities include but are not limited to the following:

　　Quality oversight of qualified utility systems (Water-for-Injection, Clean Steam, Compressed Gases)

　　Mange system leaks and incursions

　　Support deviations through drafting QNs, Gembas, and investigation issues

　　Support the management of environmental monitoring data

　　Support annual product reviews for qualified utilities

　　Mange SOP updates

　　Author annual evaluation reports, Qualifications, requalification's, and verifications of the utility system

　　Provide support to manufacturing and laboratories as needed

　　Identify and implement continuous improvement initiatives and action plans.

　　Adherence to SOPs, GMPs, and safety procedures

　　Education Minimum Requirement:

　　Bachelor's degree required. Biology, Engineering, Chemistry or related field is preferred.Required Experience and Skills:

　　Evidence of good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills.

　　Attention to detail, flexibility, and an awareness of production and associated quality problems.

　　Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical, or related fields.

　　Preferred Experience and Skills:

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

　　Strong problem-solving skills.

　　Ability to manage multiple projects/tasks simultaneously.

　　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:

　　Work Week

　　Shift:

　　1st - Day

　　Valid Driving License:

　　No

　　Hazardous Material(s):

　　n/a

　　Requisition ID: R276383