Spclst, Operations

MSD • Wilson, NC

23h • Hybrid

About The Position

POSITION OVERVIEW As part of our company's Sterile Manufacturing and Packaging Organization, the POD Manufacturing IPT is seeking a highly motivated individual to serve as a Specialist within the Operations team. In this role, you must be able to work efficiently in a fast-paced environment and be hands-on with operations and process activities. The Specialist will provide support for sterile manufacturing and packaging operations in a range of capacities including problem solving, root cause analysis, strengthening compliance posture and inspection readiness, investigating and authoring deviations related to unplanned events, among others. The Specialist must demonstrate strong collaboration and communication skills to enable interfacing with both internal and external contacts, technical writing, rapid disciplined decision making and work prioritization skills. The Specialist will support critical site project initiatives and will be involved in developing and implementing corrective actions and preventive actions. Enthusiasm for continuous learning is a requirement. Hours for position: 2nd Shift 1400-2230 Sunday-Thursday

Requirements

• High School Diploma
• Minimum of 3 years of relevant industry experience
• Demonstrated ability to work independently
• Demonstrated communication (written and verbal), collaboration, project management and data analysis skills
• Technical writing experience i.e. documentation of scientific data
• Demonstrated formal problem-solving e.g. fishbone, 5 whys

Nice To Haves

• Associate's Degree in Science, Biopharmaceutical, Business, or relevant field
• Sterile Manufacturing/Production/Packaging shop floor experience highly preferred
• Working knowledge of cGMPs and of regulatory requirements as they apply to the pharmaceutical industry
• Experience with formal problem-solving techniques and a hands-on approach to problem-solving, such as root cause analysis and/or Lean Six Sigma tools
• Experience using inventory management and maintenance planning software (MRP/ERP) such as SAP, automated control systems, electronic batch record systems (PAS-X), and change control processes
• Experience managing against metrics and scorecards in a business environment
• Experience with presenting to an internal / regulatory auditor

Responsibilities

• Assist in the review of preventative maintenance (PM) documentation
• Assist in the review of production batch documentation.
• Assist in the review of SAP inventory accuracy
• Assist with the development of sample management
• Author and revise standard operating procedures to support continuous improvement efforts and site initiatives
• Author incident and investigation reports in compliance with GMP’s and all site and global procedures
• Author special instructions and re-packaging instructions in compliance with GMPs and all site and global procedures
• Facilitate tier meetings to ensure alignment with business goals
• Support internal audits, Quality Risk Assessments, external regulatory inspections, and other site initiatives requiring Operations expertise
• Support or lead continuous improvement projects and/or change controls, applying OPPS & 8 Step methodologies to analyze errors and process failures.
• Support or lead the development and implementation of Operations related corrective and preventative actions
• Support shift leadership, collaborating with Shift Manger and Lead(s) to manage team activities and address operational challenges.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED