QC Raw Materials Analyst

Job Summary

We are seeking a motivated QC Raw Materials Analyst to ensure timely, compliant, and accurate analysis of all incoming raw materials to support seamless site operations in a fast paced GMP environment.

Responsibilities

• Sample and analyze materials such as excipients, glass vials, caps, stoppers, USB components, and packaging material.
• Retain samples for Chemistry and Packaging; update the Retain Database as required.
• Participate actively in investigations including MQI's, Vendor Complaints, LIR's, MERTS, and Trackwise items.
• Use SAP to enter results, verify that results are within specification, and perform task approval.
• Ensure compliance with EHS at all times and actively participate in EHS activities.
• Perform routine instrument calibration checks at appropriate times.
• Prepare and control Standard Operating Procedures, ensuring compliance with cGMP guidelines.
• Complete documentation for the Batch Release process.
• Assist in generating trend analysis for the group.
• Support the Internal Audit Process.
• Generate and report Key Performance Indicators for the group.
• Proactively plan for future improvements and implement them effectively.
• Develop expertise in analytical testing to resolve technical issues.
• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
• Interact with other departments such as BU, Engineering, QA, and Validation.
• Keep colleagues informed of current issues and developments.
• Assist in training and upskilling colleagues.
• Provide reasonable overtime to meet business needs when required.
• Liaise with internal and external customers including planning, QA, and Validation teams.
• Carry out additional duties as directed by the Group Leader or Supervisor.

Qualifications

• Third level Science qualification or equivalent.
• Basic pharmaceutical experience in a GMP regulated laboratory environment.
• Good communication skills.
• Flexibility and agility.
• Openness to change and proven ability to work independently and on one's own initiative.
• Willingness to work overtime as needed.

EEO Statement

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.