• Job Description

  Req#: R289491

  Job Description

  Position Description:

  This role will primarily support Virus Production at the Elkhorn site. This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally.

  This position will serve as a Quality representative in Reliance quality systems, Deviation Management and Change Controls for the Virus Department. Additionally, this role will be responsible for picking and staging Frozen Vials for the Virus Department to utilize in their production.

  They will conduct annual inspections within the IPT departments as well as assist in prioritization and execution of Quality Compliance actions assigned to the IPT. Additionally, production paperwork review will be a substantial portion of this job role. This team member will also be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management.

  This position will also share a support role for the Packaging Department serving as a Quality Representative in deviations, and change controls with the opportunity to become a Subject Mater Expert (SME) in this area.

  Additionally, this role will occasionally be assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization, critical thinking and creativity are necessary attributes for this role.

  A successful candidate will navigate the various perspectives of Planning, QA, Maintenance and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

  Additional duties will include the following:

  • Serve as a back-up to Frozen Vial Management

  • Requirement for Aseptic Gowning Certification

  • Participation in Annual Outline Review

  • Key participant in Quality Compliance Inspections from off-site entities

  • Other tasks as assigned by QA Manager and Quality Director

  Education Minimum Requirement:

  • Bachelor’s Degree (degree in the sciences preferred) or

  • Associates Degree with at least 3 years of relevant experience

  Required Experience and Skills:

  • Minimum of two to four years of QA experience

  • Strong written and verbal communication skills

  • QA knowledge of calibration records, IOPQs and SATs

  • Experience with Quality Systems including investigations and risk assessments

  Preferred Experience and Skills:

  • Familiarity and/or experience with vaccine manufacturing and/or testing

  • Strong Microbiology background

  • Familiarity and/or experience with USDA regulations and inspections

  • Project Management experience

  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

  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:

  EEOC Know Your Rights

  EEOC GINA Supplement

  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:

  Not Applicable

  Shift:

  1st - Day

  Valid Driving License:

  No

  Hazardous Material(s):

  n/a

• About the company

  Merck & Co., Inc.,

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