Associate Specialist, Operations - 2nd Shift Sunday - Thursday
Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.
The Associate Specialist, Operations supports manufacturing operations in the Barrier Operations organization. This high impact role in our Company assures that products manufactured comply with cGMPs, operating procedures and other applicable regulations. This role focuses on continuous improvement, shop floor compliance and implementation of Production Systems manufacturing initiatives aligned with department goals.
Develops an in-depth knowledge of the equipment and process.
Builds knowledge of the company, process, clients and/or customers.
Applies team effectiveness skills, listening and integrating diverse perspectives from across the workgroup.
Manage conflict and effect resolution of technical and personal challenges using standard procedures is key as is openness to change and the ability to effect positive change.
Contributes and adds value to the achievement of team goals.
Develops tools to assist with shop floor execution and operability of manufacturing processes.
Under the direction of a Senior Specialist Operations, the successful candidate will be responsible for:
Ensure compliance with safety and environmental practices, cGMPs and SOPs in the work area.
Demonstrate integrity, credibility, and flexibility in their daily performance to motivate others to do the same.
Perform a thorough real-time review of batch records and related GMP documentation, identifying and resolving discrepancies in a timely manner and implementing corrective actions to improve the batch record execution/review process.
Foster a collaborative relationship with manufacturing floor personnel focused on high quality investigations, meaningful corrective actions and reducing the deviation generation rate.
Determines/implements appropriate and effective corrective and/or preventative actions (CAPAs) to prevent reoccurrence of deviations and ensure they improve the Right First Time metrics.
Identify and escalate deviations from standard production.
Identifies and solves a range of problems in straightforward situations; analyzes possible solutions and assesses each using standard procedures.
Collaborate with Technical Operations, Quality and EMU(Engineering Maintenance & Utilities partners to escalate and identify problems with significant operational impact.
Makes decisions that are guided by site policies and procedures.
Collaborates with supporting departments such as Quality, Tech Ops and Maintenance to solve problems in an efficient and compliant manner.
Consults with manager on more complex decisions and issues that impact other departments.
Accountable for contribution to project team or sub-team, may manage/lead a small project team.
Collaborates with team members in the identification and implementation of continuous improvement initiatives and action plans.
Supports activities in the areas of cost containment, efficiency, productivity, energy conservation, waste minimization, operational excellence, and MPS practices.
Work with subject matter experts (SME’s) to provide/track necessary training for operator qualification as assigned. Develop training roadmap/plan based on production needs.
Participate in the design and implementation of training and development programs and training materials.
Collaborates with team members to ensure Time Out of Refrigeration (TOR) tag, Critical Site Review (CSR) documentation, and elogs are submitted accurately and timely.
Authors and updates technical and manufacturing documents and SOPs to support process changes, updates, and investigations.
Ensures timely and accurate reconciliation of alarms, eLogs, and filter integrity test logs.
Aware of costs and assists in controlling costs related to own work.
Education Minimum Requirement:
High School Diploma required and must have a Bachelor’s Degree prior to start date.
Required Experience and Skills:
Demonstrates strong leadership capability, problem-solving skills and a hands-on approach to problem solving.
Ability to work independently.
Willingness to work off-shift and weekends.
Preferred Experience and Skills:
0-2 years cGMP experience in a sterile, packaging, or finished vaccine manufacturing environment.
Manufacturing plant experience in operational capacity.
Experience creating and/or managing training programs.
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.
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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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.
Travel Requirements:No Travel Required
Flexible Work Arrangements:On-Site
Shift:2nd - Evening
Valid Driving License:No