Manufacturing Quality Assurance Specialist | Integrated Production Team
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.
We are seeking a Growth and Improvement minded Manufacturing Quality Assurance Specialist | Integrated Production Team that can help drive our Strategic Operating Priorities.
Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Challenges and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
The Manufacturing Quality Assurance Specialist | Integrated Production Team provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model and with guidance from the IPT Quality Lead, ensures product quality process quality to facilitate the release of product to the marketplace and ensures proper control of material through maintenance of the SAP system.
You will provide Generalist Quality support directly to the production floor, to include oversight for adherence to cGMPs, right-first-time completion of production GMP documentation, effective investigation of deviations and support for change controls and will become knowledgeable in Federal and other regulatory agency requirements and cGMPs to assure that all areas in compliance.
Job functions are completed primarily on the production shop floor and in a team environment.
Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Completes batch release of supported products, this include release to Markets outside of the USA
Collaborates with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates
Assists in sending samples/lab reagents to release authorities
Completes required SAP transactions to release product in SAP
Ensures proper identification of release status and control of materials through maintenance of quarantines in SAP and through physical tagging of material
Completes, reviews and sends release protocols to regulatory agencies
Supports Regulatory inspections | Assists in identifying and preparing documentation for review during a regulatory inspection. Serves as a subject matter expert and presents documentation to regulatory inspectors
Provides coaching and mentoring of manufacturing supervisors and operators
Conducts Quality review / approval of new and updated SOPs and CJAs
Assists with training of incoming personnel and ensures compliance with departmental procedures
Actively participates in the Tier process and uses this forum to escalate concerns and best practices
Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans
Required | High School Diploma/Equivalent
Preferred | Bachelor degree in life science, science discipline, or engineering field | Note: Candidates with a Bachelor degree in other fields will be considered with experience listed under Experience | Skills | Knowledge
Experience | Skills | Knowledge
High School Diploma/Equivalent with four years direct experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting or Bachelor degree with one year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations, or related industry experience in a laboratory, manufacturing, science related or regulated setting
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.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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Travel Requirements:No Travel Required
Flexible Work Arrangements:
Shift:1st - Day
Valid Driving License: