Quality Specialist

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

Position Overview – Basic Functions & Responsibility

The Quality Specialist provides direct Quality assistance to a production area as part of a Quality IPT (Integrated Product Team) operating model. The Quality Specialist, with guidance from the Quality Manager or IPT Quality Lead, ensures product/process quality, represents Quality on the shop floor, and performs activities to facilitate the release of product to the marketplace. The Quality Specialist will work closely with IPT in a team environment to ensure timely review of documentation is Right First Time (RFT). The incumbent will: provide assistance to the production floor when needed, ensure adherence to cGMPs, complete batch disposition activities for release of product, and assist with investigation of deviations. Additionally, the Quality Specialist, collaborates with Operations, Laboratory Operations, Technology, and Planning to enable RFT production, learn the manufacturing process, and ensure compliance with cGMPs and regulatory requirements.

• Becomes fully trained in relevant Standard Operating Procedures (SOPs).
• Learns cGMPs, the manufacturing process, laboratory operations and our company's quality systems, including SAP, LIMS and electronic logbook, laboratory data, and batch record platforms.
• Review/Approval of documentation within the IPT to ensure compliance with cGMPs and regulatory requirements.
• Executes quality checks and SAP transactions needed to release all Lyo product, domestic and international, including international country evaluations and documentation
• Partners with IPT members in the identification and implementation of continuous improvement initiatives and action plans.
• Participate in Quality Observation for Process Simulations.
• Performs Quality review/approval of new and updated SOPs and Controlled Job Aides. Ensure compliance with departmental procedures.
• Actively participate in the Tier process and use this forum to make concerns visible and to partner with Laboratory Operations on resolution.
• Aids in investigations and protocol executions
• Author/Approve reports, protocols, summary reports, SOPs, job aids and other GMP documents.
• Foster a customer service attitude within the E2E.
• Partners with Planning, Operations and Technology organizations to ensure batches are ready for release by appropriate due dates.
• Assists with training of incoming personnel and ensures compliance with departmental procedures.
• Actively participates within and provides assistance with internal audits and regulatory inspections.

Education:

• Bachelor's degree, in a scientific or engineering field (preferred); Technical emphasis in an appropriate scientific or engineering field preferred; candidates with degrees in other fields will be considered if accompanied by significant relevant experience.

Qualifications and Skills:

• At least one year of relevant post-degree work experience in a laboratory, manufacturing, or quality position.
• Evidence of leadership skills coupled with good oral and written communication skills.
• Effectiveness and creativity in approaching and solving technical problems

- Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.- Demonstrated interpersonal skills including flexibility, partnership and inclusion skills and ability to work in a team environment

Preferred Qualifications and Skills:

• Experience in quality systems, pharmaceutical manufacturing processes, authoring and approving GMP documents.
• Knowledge of Aseptic gowning preferred but not required.
• Exposure ton Domestic and international release, material control activities, quality deviations, scheduling, and metrics reporting
• Demonstrated analytical aptitude, critical thinking skills and problem-solving skills.
• Demonstrated ability to upskill / coach others.
• Titers may be required

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., Kenilworth, 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 …

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com