Quality Assurance Technician

Job Description

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 dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

This role will support manufacturing operations and will be primarily responsible for the review of completed production batch documents. This Quality Assurance colleague will ensure documentation for the Downstream (Blend, Fill and Packaging) Integrated Production Team (IPT) is complete and compliant. This team member will provide documentation guidance from a quality compliance perspective having knowledge of local and global Animal Health standards, USDA regulations, and cGMP generally. Document reviews will be tracked and prioritized based on target release dates and will assist the IPT in tracking and prioritizing their reviews to me target dates. This includes regular communications as to review status to groups both downstream and upstream of document review. The ideal candidate will have ability to maintain detailed focus while reviewing paper documents for significant portions of their workday.

The Quality Assurance Technician will also work closely with the Downstream IPT, alongside other members of Quality Assurance to provide quality support in multiple ways including assisting in inspections, investigations and compliance actions assigned to the IPT.

This team member will be located in a clean manufacturing lab environment. While approximately 80% of their role will be in an office setting, they will also be expected to regularly spend time within the manufacturing areas to learn processes, evaluate compliance and build relationships of trust with production operators and management.

This position will also share a support role for the inspection of printed packaging components, and physical management of frozen vial inventory managed by QA. 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 responsiblies 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 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.

Additional duties will include the following:

• Assist with the QA portion of Sterile Media Simulations

• Requirement for Aseptic Gowning Certification

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

• Other tasks as assigned by QA Manager and Quality Director

Minimum Education/Experience Requirement:

• H.S Diploma with minimum of 3 years of work history (science driven career 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 SystemsFamiliarity and/or experience and experience with SAP or similar systems

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Residents of Colorado

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For positions located in the United States and Puerto Rico – Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) (“Customer-Facing Role”) who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

Residents of Colorado:

Click here to request this role’s pay range.

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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R203256