Spclst, Quality Control

Job Description

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.

Additional Responsibilities

General

• 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

Business & Functional Expertise

• Completes assignments in alignment with department objectives

• Authoring of Laboratory deviations and supporting deliverables such as investigational protocols, reports.

• Authoring of Corrective Action and Preventive Action, and Batch Quality Notifications

• Authoring Standard Operating Procedures

Problem Solving

• 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)

Impact

Influence

• Communicates information, asks questions and checks for understanding

Accountability

• Accountable for own performance

Decision Making

• Makes decisions – guided by policies and procedures – on the shop floor

• Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes

Shift

1st Shift Days (Mon-Fri)

Education Requirement

• Bachelor of Science degree in Biology, Chemistry, Biochemistry, or related field

Required Experience and Skills

• Minimum 2 years related experience

• Understanding and application of Good Laboratory Practices and cGMPs

• Working in a team environment

• Deviation Management experience

Preferred Experience and Skills

• Strong verbal and written communication skills
   

Working Relationships

• Reports to Quality Control department head

• Interacts with employees within own department and other departments

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