Senior Technician, Quality Assurance

Job Description

Summary:

This role will support manufacturing operations and will be primarily responsible for the review and labeling of raw material and review of printed material documentation.  This Quality Assurance colleague will ensure documentation for these two areas are complete and compliant.  Additionally, this role will serve to update and maintain Master Data within SAP, review occasional production batch records.  The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday. 

The Quality Assurance Senior Technician will also work closely with other members of Quality Assurance as well as internal and external customers to ensure materials are being released as they are needed by the rest of the site.

This position is expected to become a back-up for various QA functions within the team as well as assist with quality systems tasks such as, deviations and change controls. The ideal candidate will seek opportunities to develop competency in the multiple Quality Assurance functions and systems and assist in various projects and responsibilities within the QA and manufacturing team.  

This role will be occasionally assigned short term tasks and projects with varying degrees of urgency and difficulty and thus organization is a desired trait.  The ideal candidate will have attributes of critical thinking, problem solving and disciplined judgement which will allow them to excel on a specialized and dynamic Quality Assurance team. 

A successful candidate will be able to navigate the various perspectives of Planning, QA and Production utilizing Leadership Behaviors and principals of Inclusion, while holding Safety and Quality as primary values.

Key Responsibilities:

• Labeling, Document Review and Release of Raw Materials

• Review and Release of Printed Material Components

• Update and Maintain SAP Master Data

• Assist with Change Controls and Deviations

• Review of production batch records on an intermittent basis

Additional duties will include the following:

• Participate in yearly site-wide QA Self Inspections

• Key participant in Quality Compliance Inspections from regulatory agencies and off-site entities

• Become trained as a back-up for several QA tasks

• Other tasks as assigned by QA Manager and Quality Director

 

Minimum Education/Experience Requirement:

• H.S Diploma with 5 years of relevant experience OR

• Associate degree with at least 3 years of relevant experience OR

• Bachelor’s degree (degree in the sciences preferred)

Preferred Education, Experience and Skills:

• Degree in microbiology, chemistry, or similar scientific discipline.

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

• Familiarity and/or experience with USDA and/or FDA regulations and inspections

• Experience in GMP and Quality Management Systems

• Familiarity and/or experience with SAP, Reliance or similar systems

#MSJR

Required Skills:

Accountability, Accountability, Batch Record Review, Biogeochemistry, Chemical Biology, Chemistry, Corrective and Preventive Action (CAPA), Document Control Systems, FDA Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Immunochemistry, ISO 14000, ISO 9000, Laboratory Information Management System (LIMS), Manufacturing, Master Data Management (MDM), Microbiology, Molecular Microbiology, Quality Assurance (QA), Quality Auditing, Quality Improvement Programs, Quality Management, Quality Management System Implementation, Quality Management Systems (QMS) {+ 5 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:

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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:

12/1/2025

*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.