Associate Specialist, Quality Assurance

Merck & Co.; Elkhorn Precinct (NE); On-site; USD 72,000 - 113,000; Full time

Job summary

Merck & Co., Inc. is seeking a QA professional at our Elkhorn site to provide quality compliance guidance, review deviations and change controls, and support documentation for FPP release and batch issuance.

Collaboration across Planning, QA, Maintenance, Engineering, and Production will be essential to uphold safety and quality values. The role requires knowledge of cGMP, regulatory expectations, and experience with QA investigations.

Qualifications

• Minimum 2 years in a regulated industry (pharma, biologics, medical devices, or aviation/military).
• Strong written and verbal communication; cross-functional collaboration.
• Foundational QA knowledge of deviation management and change control.
• Experience with QMS, investigations and risk assessments.

Responsibilities

• Perform and assist other QA team members with internal Self-Inspections (site walkthroughs and audit-readiness reviews).
• Serve as the primary back-up to a number of critical site QA roles and functions.
• Key participant in Quality Compliance Inspections from external regulatory and off-site entities.
• Support visual management systems (QA T-Card tracker) and batch release administrative workflows.
• Other tasks as assigned by the QA Manager and Quality Senior Leaders.

Skills

Analytical

Aseptic Filling

cGMP Compliance

Complaint Management

Decision Making

Deviation Management

GMP

Quality Auditing

Quality Management Standards

Quality Management Systems

Quality Standards

Quality Support

Root Cause Analysis

Technical Writing

Training and Development

Education

High School Diploma

Associate's Degree

Bachelor's Degree

Tools

Reliance

SAP

MEDS

Job description

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 the Services IPT (Integrated Process Team) at the Elkhorn site. This team member will provide guidance from a quality compliance perspective, leveraging knowledge of local and global Animal Health standards, USDA regulations, and general cGMP principles. 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 the Services IPT and other departments.

This position will serve as a Quality representative in Reliance quality systems, Deviation Management, and Change Controls for the Services IPT group. This role will review process deviations, change controls, and other qualification documents for QA to ensure regulatory requirements are being followed. Additionally, this team member will assist with release activities for FPP (Final Packaged Product) and support documentation review activities, batch issuance, and other documentation administration tasks.

Additionally, this role will occasionally be assigned short-term tasks and projects with varying degrees of urgency and difficulty; therefore, organization, critical thinking, and creativity are necessary attributes for success.

A successful candidate will navigate the various perspectives of Planning, QA, Maintenance, Engineering, and Production utilizing established Leadership Behaviors and principles of Inclusion, while holding Safety and Quality as primary values.

Additional Duties & Responsibilities:

• Perform and assist other QA team members with internal Self-Inspections (site walkthroughs and audit-readiness reviews).
• Serve as the primary back-up to a number of critical site QA roles and functions.
• Key participant in Quality Compliance Inspections from external regulatory and off-site entities.
• Support visual management systems (such as the QA T-Card tracker) and batch release administrative workflows.
• Other tasks as assigned by the QA Manager and Quality Senior Leaders.

Required Education & Experience:

• High School Diploma-with at least five (5) years of relevant industry experience OR
• Associate's Degree-with at least three (3) years of relevant industry experience- OR
• Bachelor's Degree-(degree in the sciences preferred)-

Required Experience and Skills:

• Minimum of two (2) years of experience working in a regulated industry (e.g., Pharmaceuticals, Biologics, Medical Devices, or Aviation/Military).
• Strong written and verbal communication skills with a demonstrated ability to collaborate cross-functionally.
• Foundational QA knowledge of deviation management and change control processes.
• Hands-on experience navigating quality management systems, including participating in investigations and risk assessments.

Preferred Experience and Skills:

• Familiarity and/or direct experience with vaccine manufacturing and/or biological testing.
• Familiarity with USDA regulations (9 CFR) and regulatory inspections.
• Prior experience utilizing standard enterprise systems such as Reliance, SAP (S/4HANA), and MEDS.
• Knowledge of lean manufacturing or continuous improvement frameworks such as Standardized Work and On-Point Problem Solving (OPPS).
• Strong Microbiology, Biology, Chemistry, or Engineering background.
• Basic Project Management experience.

#MSJR

Required Skills:

Analytical Problem Solving, Aseptic Filling, cGMP Compliance, Complaint Management, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Quality Auditing, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Technical Writing, Training and Development

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.

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

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 .

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: 09/24/206E