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.
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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:
- High school diploma or equivalent with 5 years of relevant experience OR
- Associate's degree with at least 3 years of relevant experience OR
- Bachelor's Degree (degree in the sciences preferred)
Required Experience and Skills:
- Minimum of two years of experience within a regulated industry.
- Experience with 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
MSJR
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:
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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.
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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, Monday - 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".
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:
11/6/2024
*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.
Requisition ID:R319707