Quality Control Specialist

Quality Control Specialist

Lonza

Porriño, Spain

As part of our team, the QC Specialist is considered a subject matter expert for one or more areas. This person will be an overall QC representative acting as a liaison between the QC Laboratory and its internal and external customers. The team member will work on assignments that are moderately complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. In addition this person will work on moderately complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.

Key Responsibilities:

• Participate in multiple internal and customer project teams as Quality Control representative
• Tracks QC testing, manages project commitments, follows through on action items, coordinates analytical teleconferences and participates in problem solving of issues
• Track and compile product data and present to internal and external customers and drive associated process change controls/deviations
• Independently drive projects to on-time completion
• Initiation and completion of necessary process change controls, deviations and laboratory investigation reports
• Responsible for tech transfers and methods validation in the laboratories
• Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee the activities of other QC personnel
• Ensure regulatory and customer inspection readiness and represent the department and participate in audits as required
• Supervisor back up, if needed
• Other – work on non-routine assignments, problem solving, manage project commitments
• Perform other duties as assigned

Key Requirements:

• Associate's or Bachelor's degree preferred in science related field, or industry based experience in Quality Control
• GMP knowledge required
• Minimum 2 years of previous quality experience required
• Communication skills in English required
• Previous lab experience preferred
• Experience with protocol writing preferred
• Experience with writing reports, documentation control, and SOP review preferred
• Experience with LIMS, Trackwise, Empower preferred

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