Job Description
This role will primarily support the Services IPT (Integrated Process Team) as well as 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 the Services IPT group and Engineering and Maintenance departments. This role will review process deviations, change controls, IOPQs and other qualification documents for QA to ensure regulatory requirements are being followed and so 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:
Required Experience and Skills:
Minimum of three years of QA experience
Strong written and verbal communication skills
QA knowledge of deviations, change controls, 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
Required Skills:
Aseptic Manufacturing, Aseptic Manufacturing, Audits Compliance, Calibration Management Software, Calibration of Equipment, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Manufacturing Compliance, Oral Communications, Preventive Action, Preventive Maintenance, Quality Assurance (QA), Quality Assurance Monitoring, Quality Assurance Processes, Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Regulatory Compliance, Regulatory Requirements, Root Cause Analysis (RCA), Supplier Quality Management {+ 1 more}
Preferred Skills:
Current Employees apply
Current Contingent Workers apply
The salary range for this role is
$87,300.00 - $137,400.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at .
You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
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:
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
Job Posting End Date:
07/30/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
