Specialist, Quality Systems & Compliance

Merck•Durham, NC

1d•$71,900 - $113,200•Onsite

About The Position

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Associate Specialist provides Quality support to both laboratory and manufacturing operations. The successful candidate will have the opportunity to apply their enthusiasm and skills as a member of a multidisciplinary team supporting the operation of vaccine product manufacturing facilities. The successful candidate must be able to examine issues from various perspectives, provide a hands-on approach to problem solving, and be self-motivated to identify and initiate process improvement projects. The Quality Assurance Specialist provides support to vaccine, biologic, and sterile manufacturing processes through collaboration with Technical Operations.

Requirements

High School Diploma or equivalent.
Minimum two (2) years’ experience in Manufacturing, Maintenance, Military environments, or relative industry experience.
Must be able to work 12 hour night shift 6:00 pm to 6:00 am; 2-2-3 schedule.
Analytical Problem Solving
Aseptic Filling
cGMP Compliance
Communication
Complaint Management
Decision Making
Deviation Management
Global Manufacturing
Good Manufacturing Practices (GMP)
Manufacturing
Oral Communications
Performance Improvement Plans
Problem Solving
Process Improvement Projects
Process Improvements
Quality Assurance (QA)
Quality Auditing
Quality Management
Quality Management Standards
Quality Management Systems (QMS)
Quality Standards
Quality Support
Root Cause Analysis (RCA)
Sterile Procedures

Nice To Haves

Good interpersonal skills including flexibility and collaboration.
Demonstrated analytical aptitude, critical thinking skills, and problem solving.
Good verbal and written communication skills.

Responsibilities

Perform review of batch records, laboratory records and associated documentation.
Provide quality guidance and assistance in deviation identification and initiation.
Perform data review and run reconciliation activities as required (i.e., UV and FIT testing).
Learn new processes and procedures.
Perform shift work as required.
Support housekeeping and self-inspections.
Perform Quality retain sample management activities, if applicable.