Assoc. Specialist, Operations Quality Job Opening

Job Description

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 Elkhorn Downstream Manufacturing Process Team is seeking a highly motivated individual to fill the position of Operations Quality Associate Specialist, within our Manufacturing Division.

This position is responsible for leading critical production projects and process improvement initiatives within the blending, sterile filling and packaging operations. The candidate must possess strong problem-solving and troubleshooting skills and be able to provide guidance around product impact from technical or compliance deviations with minimal supervision.

The individual must embrace and be committed to establishing an empowered team culture, with the goal of each employee reaching their fullest potential and having accountability, authority and responsibility to one another, our community and our customers. Enthusiasm for continuously learning and imparting that knowledge on others is a requirement.

Primary responsibilities include, but are not limited to the following:

• Write event notifications to document atypical events in production and lead investigations as necessary.
• Provides technical support and oversight on the production floor. Understanding the process requirements (safety, compliance, equipment, regulatory) in order to resolve production issues with little assistance, using formal problem-solving techniques.
• Collaborate with other departments, such as Quality, Environmental Health and Safety, Upstream manufacturing, Maintenance, Planning and Technical Support to ensure alignment of goals.
• Review and revise processes and procedures against corporate and regulatory requirements to ensure compliance.
• Planning, organizing, leading and implementing preventative actions as they relate to investigation outcomes.
• Participates in safety initiatives, investigations, and walk throughs.
• Attend departmental and team meetings focused on equipment, process, and training improvement.
• Complete SOP updates as required.
• Communicating with team members and sponsors.
• Develop process improvement procedures to improve operational efficiency.
• Perform data gathering, SAP data entry and documentation review, root cause analysis, and performance trending to support appropriate process control changes.

Education Minimum Requirement:

• High School diploma/GED with a minimum of 2 years of laboratory or related production experience -OR- Associates Degree with a minimum of 1 year production experience -OR- Bachelor's degree. Biology degree preferred.

Required Experience and Skills:

• Ability to gown into and work within an aseptic environment.
• Strong computer skills including experience with MS Office Suite (Word, Excel, etc.)
• Strong verbal and written communication skills
• Possess problem-solving skills and able to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve it at root cause.

Preferred Experience and Skills:

• 1 year experience in USDA or similarly regulated manufacturing environment.
• Data analysis and trending experience.
• Technical writing experience preferred.
• SAP experience.

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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.

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.

If you need an accommodation for the application process please email us at [email protected]