Associate Specialist, Quality Assurance

Job Description

For over 130 years, we have pioneered groundbreaking science.  Today, we are driven by continuous innovation to develop breakthrough medicines, vaccines and technology.  Rooted in direct experience on the farm and in the clinic, we work hand in hand with our customers every step of the way.

Our singular focus is to empower those who care for animals, helping them manage their vital responsibility with confidence.  Because when it comes to animal health, no one sees it like we do.

This role will primarily support Manufacturing Operations and will serve as the Quality Integrated Process Team (IPT) Representative for the Fermentation and Downstream and Single Use Bioreactors (SUBs) manufacturing areas. 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. Primary responsibilities include:

Quality Integrated Process Team (IPT) Representative

• Review and Approve Fermentation / Downstream and SUBs batch records.

• Provide generalist Quality support directly to production

• Prepare batch record documentation and perform review for compliance to ensure good documentation practices against established SOPs/standards.

• Resolves minor issues found during documentation review (documentation errors, missing information) as directed by SOP.

• Resolves major issues that are not defined by SOP.

• Quality representative in daily Tier 1 meetings

• Collaborates with IPT members in the identification and implementation of continuous improvement actions.

• Provide seeds for the departments to initiate scale up processes.

• Serve as backup for other assigned areas assigned by QA management

• Support with document filing and archival

• Resolves major issues that are not defined by SOP.

Deviation management/CAPA

• Author or support in investigations for determination of root cause and impact assessment

• Assess, review, and area approve assessment of impact to recommend disposition of any impacted products

• Support with classifications and reviews for events & CAPA.

• Completes Corrective Action and Preventive Action as assigned

• Performs follow up for Corrective Action and Preventive Action completion

 

Change management

• Support, track and assure completion of change control documentation

• Completes change control action items as assigned

• Performs review and approval of change controls as a Quality Representative in Quality Assurance

• Assist with revising existing documents and procedures. Creates and updates Quality Assurance procedures as needed.

 

Inspection Readiness

• Conduct monthly Quality Gemba walks within the departments, assists in prioritization and execution of Quality Compliance actions assigned to the area.

• Conduct and maintain Inspection readiness across the site.

• Support with Animal Health Quality Manual updates for Self-Inspection as Site System owner or Subject Matter Expert.

 

Training

• Completes all training by assigned due date

• Crosstrain on other functions within the Quality Assurance department

 

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 successful 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.

Education Minimum Requirement:

• Associate’s Degree with 5 years of relevant industry experience required.

• Bachelor’s Degree required, degree in the sciences preferred.

Required Experience and Skills:

• Minimum of two 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, Aera and Reliance or similar systems.

• Excellent attention to detail

• Takes decisions with minimal supervision by defined processes and the knowledge to escalate for management review when required.

• Exceptional problem-solving skills to identify logical solutions to challenges

 

Preferred Experience and Skills:

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

• Strong Microbiology background

• Familiarity and/or experience with USDA regulations and inspections, and knowledge regarding the Animal Health Quality Manual.

• Project Management experience.

Required Skills:

Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Complaint Management, Critical Thinking, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Inspection Readiness, IT Demand Management, Molecular Microbiology, Prioritization, Process Scale Up, Quality Assurance (QA), Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Process Development, Quality Standards, Quality Support, Regulatory Inspections, Risk Assessments {+ 2 more}

Preferred Skills:

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”.

The salary range for this role is

$71,900.00 - $113,200.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

04/29/2026

*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.