Spclst, Quality Control

Merck & Co. • Durham, NC

272d • Onsite

About The Position

Our Quality 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 main function of the Specialist, QC Deviation Management is to initiate/author laboratory deviations (Incidents and investigations) in response to Quality Control events.

Requirements

• Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field.
• Minimum 2 years related experience.
• Understanding and application of Good Laboratory Practices and cGMPs.
• Working in a team environment.
• Deviation Management experience.

Nice To Haves

• Strong verbal and written communication skills.

Responsibilities

• Interacts with other areas including Quality Assurance, Validations and Production as needed to collaborate on the resolutions of events.
• Supports the execution of CAPAs and continuous improvement actions.
• Evaluates data, conducts trouble shooting, process improvements, report writing, involvement in interdepartmental committees and projects.
• Completes assignments in alignment with department objectives.
• Authors Laboratory deviations and supporting deliverables such as investigational protocols, reports.
• Authors Corrective Action and Preventive Action, and Batch Quality Notifications.
• Authors Standard Operating Procedures.
• Identifies and resolves technical and operational problems in collaboration with colleagues and under guidance from department head.
• Performs robust root cause analysis leveraging on MPS tools (ECF, Causal Branching, LFT, Defense analysis, etc).
• Communicates information, asks questions and checks for understanding.
• Accountable for own performance.
• Makes decisions - guided by policies and procedures - on the shop floor.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree