Spclst, Quality Assurance

Job Description

Quality Assurance Specialist Department.

Our Quality Assurance group ensures every single material inside our products is manufactured processed tested packaged stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant reliable supply to customers and patients on time every time across the globe.

The Quality Assurance Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities. The successful candidate must be able to examine issues from diverse perspectives provide a hands-on approach to problem solving and be self-motivated to identify and lead process improvement projects.

The Quality Assurance Specialist provides support to vaccine biologic and sterile manufacturing processes through collaboration with Technical Operations.

Primary Activities Could Include :

Executes critical site review and review of environmental monitoring data.

Perform review of batch records and documentation.

Perform review of process simulation batch records.

Perform data review and run reconciliation activities as required (i.e. UV and FIT testing).

Perform Quality retain sample management activities.

Lead housekeeping and self-inspections.

May approve incidents and investigation related to deviation management.

Assists cross-functional team with executing and approving change controls.

Approve cleaning validation documentation as needed.

Learn new processes and procedures.

Perform shift work as needed.

May act as a Quality Risk Assessment Lead.

Skills

Education Minimum Requirements :

High School Diploma or equivalent

Required Experience and Skills

Minimum four (4) years experience in Manufacturing Maintenance Laboratory or Military environments.

including two (2) years experience in an GMP or FDA regulated industry.

Preferred Experience and Skills

Demonstrated interpersonal skills including flexibility and collaboration

Demonstrated analytical aptitude critical thinking skills and problem solving

Demonstrated ability to upskill others

Demonstrated verbal and written communication skills

Experience in pharmaceutical related environment

#MSJR VetJobs #EBRG #SHPE2025

Required Skills :

Accountability Accountability Aseptic Manufacturing Audits Compliance Cleaning Validations Corrective and Preventive Action (CAPA) Critical Thinking Detail-Oriented Documentation Review Driving Continuous Improvement Environmental Monitoring GMP Compliance IS Audit Multidisciplinary Collaboration Problem Solving Process Improvement Projects Process Simulation Quality Assurance (QA) Quality Assurance (QA) Standards Quality Assurance Tools Quality Auditing Quality Management Systems (QMS) Quality Risk Assessment Quality Standards Root Cause Analysis (RCA) 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 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 anothers 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 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

$85600.00 - $134800.00

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 employees 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 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) :

Cleaning Supplies

Job Posting End Date :

11 / 13 / 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.

Key Skills

Test Cases,SQL,Quality Assurance,Agile,TFS,Jira,Software Testing,Test Automation,Cucumber,QA / QC,SDLC,Selenium

Employment Type : Full-Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 85600 - 134800