Merck & Co Hiring for Quality Assurance Specialist job in Elkhorn Full Time

Job Description

Position Description:

This role will primarily support Engineering and Maintenance 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 team member will also be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust within these departments.

This position will serve as a Quality representative in Reliance quality systems, Deviation Management and Change Controls for Engineering and Maintenance departments. -This role will review IOPQs for QA to ensure new equipment is properly qualified per applicable regulatory requirements.- Additionally, this team member will work closely with the calibration team, overseeing improvements to the calibration quality at the site.

Another aspect of this role is to become familiar with Preventive Maintenance activities being performed around the site and ensure that these tasks are being performed as requested and documented correctly.

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, Engineering and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Perform and assist other QA team members with internal Self-Inspections
• Serve as the back-up to a number of critical QA roles and functions
• 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)

Required Experience and Skills:

• Minimum of three to five 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 Engineering 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

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US and Puerto Rico Residents Only:

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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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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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R288851