GMP Operations Specialist — Night Shift Leader & Troubleshooter

1000 Merck Sharp & Dohme LLC; North Carolina; On-site; USD 79,000 - 125,000; Full time

Job summary

MSD in Durham, NC is seeking an Operations Specialist for a 3rd shift on a rotating 2-2-3 schedule. The role focuses on shop floor execution, batch closeout, and troubleshooting to improve department performance within a GMP environment.

Responsibilities include SOP authoring, batch/eLog review, safety investigations, CAPA coordination, and cross-functional collaboration with operations leaders. Requires strong communication and ability to mentor new staff.

Qualifications

• GMP experience required.
• Strong written and verbal communication skills.
• Ability to foster a collaborative work environment.
• Flexible and able to manage multiple priorities.
• Experience with SOPs and batch records.

Responsibilities

• Partner with operations management to implement production strategies and drives continual improvement.
• Author SOPs and perform document reviews.
• Batch Record Review and eLog Review.
• Lead safety investigations and CAPA activities.
• Lead problem-solving initiatives on the shop floor.
• Troubleshoot equipment and processes on shift.
• Coordinate with on-shift Operations Coaches (M1).
• Lead implementation of MPS principles on the shop floor.

Skills

Batch Record Review

CAPA Management

GMP Compliance

Data Analysis

Process Troubleshooting

Production Planning

Project Management

Regulatory Compliance

Team Leadership

Lean Manufacturing

Education

High School Diploma

Bachelor's in Technical Field

Tools

SAP

Job description

MSD in Durham, NC is seeking an Operations Specialist for a 3rd shift on a rotating 2-2-3 schedule. The role focuses on shop floor execution, batch closeout, and troubleshooting to improve department performance within a GMP environment.

Responsibilities include SOP authoring, batch/eLog review, safety investigations, CAPA coordination, and cross-functional collaboration with operations leaders. Requires strong communication and ability to mentor new staff.