Job Description

Position Description:

This role will primarily support Manufacturing Operations and will serve as the primary Quality Assurance Representative for the Downstream (Blend, Fill and Lyophilization) Integrated Production Team (IPT). This team member will provide guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMPs.

This position will serve as the Quality Point of Contact for any quality issues the Downstream IPT has. Additionally, this role will serve as the Quality Assurance Representative on Downstream Quality Systems Records. These records include Deviations, Change Controls, SOP updates, Batch Record updates and more.

This team member will be expected to regularly spend time within the department to learn processes, evaluate compliance and build relationships of trust with production operators and management. They will report on site metrics, assist in prioritization and execution of Quality Compliance actions assigned to the IPT, and assist with Downstream batch record review on an as-needed basis.

This position will also serve as the primary back-up Quality Assurance Representative for Maintenance and Engineering assisting in the approval of qualification and validation documents on equipment and software systems. Additionally, they will review and approve calibration records and assist with non-conformance related issues.

Additionally, this role will be occasionally 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 successfully candidate will navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Additional duties will include the following:

• Site System Owner of Sterile Media Simulation

• Requirement for Aseptic Gowning Certification

• Perform and assist with Internal Self-Inspections

• Help provide coverage for absences throughout the QA department

• 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 (in the sciences preferred)

Required Experience and Skills:

• Minimum of five years of Quality experience in a regulated industry.

• Strong communication skills both written and verbal.

• Experience with investigations, risk assessment, and regulatory inspections.

• Skilled in technical writing.

• Candidates have experience in SAP and Various Quality Systems

Preferred Experience and Skills:

• Familiarity and/or experience with Downstream vaccine manufacturing

• Strong Maintenance and Engineering background

• Familiarity and/or experience with USDA regulations and inspections

• Project Management experience

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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, 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:

05/21/2025

*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.