Senior Specialist, Manufacturing Quality ( MERCUSR179613ENUS)
New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.
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 interlinking global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
We are seeking Growth and Improvement minded Senior Manufacturing Quality Specialists 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 dedicated 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
With guidance from the Integrated Product Team (IPT) Quality Operations Leader or E2E Quality Operations Leader, the SMQS ensures product/process quality through the review of GMP documents, facilities and processes and performs activities to ensure the reliable release of quality products to the marketplace. The SMQS ensures all necessary documentation (CRs, IQ/OQs, PQs, etc.) is approved, valid, and complies with all Regulatory and our Manufacturing Division requirements and is responsible for working closely with the various groups within the assigned IPT or E2E in a team environment to enable the timely release of product to the marketplace.
Additional Key Responsibilities
Manages aspects of the material control and/or release process as it relates to control of material for investigations and risk processing.
Accountable for compliance to cGMPs on the shop floor for assigned IPT or E2E.
Partners with personnel in Operations, Technology, and Planning to resolve issues, support investigation completion and approval, provide recommended production dispositions and corrective actions where appropriate.
Conducts review and approval of quality notifications for assigned IPT or E2E | Review and close-out of CAPAs and QCTS commitments within assigned IPT or E2E
Manages review and completion for Change Requests for assigned IPT or E2E | Review and approval of IQ/OQ/PQ for assigned IPT or E2E
Completes GMP walkthrough inspections within IPT or E2E to ensure compliance with cGMPs and regulatory requirements
Supports risk processing of material within the IPT or E2E through collaboration with Operations, Technology, and Planning
Completes review and approval of Master Batch Records (MBRs), LIMS CRs, ACRs, etc.
Supports the preparation of regulatory filings by providing data and review
Maintains an expansive knowledge of GMPs, our Company Manufacturing Policies, Guidelines and Procedures, regulatory guidance, evolving regulatory trends, and the working mechanics of our Manufacturing Division
Provides guidance to Operations and Laboratory Operations on quality issues based upon experienced and mature judgment and utilizes strong interpersonal skills to work with a diverse group of personnel in handling non-routine issues
Writes, reviews, and approves Standard Operating Procedures, Controlled Job Aides, Control Procedures, Quality Standards, etc.
Represents Quality on assigned project teams and leads those projects relevant to Quality within the IPT or E2E | Develops/updates systems on the aspects of material control/product release/shop floor compliance/deviation management within the established policies and guidelines
Supports company strategic, departmental operational excellence and manufacturing regulatory initiatives | Serves as the quality representative on capital projects
Participates in site inspection/audits by facilitating discussions with inspectors/auditors, fulfilling requests for information and presenting to inspectors on required topics as Quality representative for assigned IPT or E2E
Acts as a liaison with the Laboratory to prioritize the testing of samples to meet supply and schedule adherence needs and to work with the laboratory on optimization of cycle times
Provides training to incoming personnel and ensures compliance with departmental procedures
Bachelor's degree in appropriate scientific/engineering field or related area of study.
Work independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
Five years in a Quality Control, Quality Assurance, Manufacturing environment or related field
Demonstrated analytical and problem-solving capabilities
Principled verbal and written communications
Batch release and Deviation Management.
Strong understanding of regulatory requirements and cGMPs
Demonstrated leadership competence
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed 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.
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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.
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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.
Flexible Work Arrangements:
Shift:1st - Day
Valid Driving License:No
Number of Openings:10