Associate Specialist - Operations

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.

Position Description

As part of our company's Vaccine Manufacturing Organization, the Durham VMF team is seeking a highly motivated individual to serve as an Associate Operations Specialist within the Operations Technical Services team.  In this role, you must be able to work efficiently in a fast-paced environment and be hands-on when called for by the situation.  This role is responsible for product sample delivery and document coordination that supports VMF101/102 production. The position must also demonstrate strong collaboration and communication skills to enable interfacing with both internal contacts (site level) and external contacts (external customers, sister sites, vendors).

 
Responsibilities include, but are not limited to:

• Responsible for the generation and review of sample lab documentation/labels

• Review/inspection/delivery of samples

• Coordinate shipping documentation and sample preparation for domestic and international shipments to applicable health authorities and intra-site

• Author and own execution of Operations protocols

• Assist in the development of and own Operations corrective actions

• Author and revise Standard Operating Procedures

• Support of internal and external regulatory inspections, presenting on topics as needed.

• Leads/Supports production and quality projects and process system improvements

• Provide expertise to the production floor, understanding the full process requirements (safety, compliance, equipment, regulatory) in order to best understand and resolve production issues.

• Works independently and is capable of balancing shifting priorities without introducing disruption to the organization. Capable of working through uncertainty with minimal levels of manager direction.

Education Minimum Requirement

• Bachelor's degree in a Science or Production related field required.

Required Experience and Skills

• Technical writing experience, i.e. investigations, change requests, standard operating procedures, batch records, protocols.

• Must be able to work both independently and within multi-functional teams in a fast-paced environment.

Preferred Experience and Skills

• At least one year of experience in a Good Manufacturing Practices (GMP) environment.

• Experience with sample management

• Sterile manufacturing shop floor experience highly preferred.

• Working knowledge of cGMPs and of regulatory requirements as they apply to the vaccine/pharmaceutical industry.

• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP and Laboratory Information Management Systems (LIMS)

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals 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., 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. DurhamEng

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
 

For more information about personal rights under Equal Employment Opportunity, visit:

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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.

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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. 

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R110906