Job Description Summary
The QC Analyst is responsible for performing routine analytical testing on Finished Product samples in compliance with current Good Laboratory Practices (cGLP) and Good Manufacturing Practices (cGMP). The role ensures timely turnaround of results while maintaining high standards of accuracy and documentation. Analytical techniques include, but are not limited to, HPLC, Osmolality, Organic and Inorganic Iodine, Thin Layer Chromatography, Free Aromatic Amines, pH, Refractive Index (RI), Trom's, EDTA, Technical Tests, Extractable Volume, and complaint sample analysis.
Job Description
Responsibilities
* Assisting in the maintenance of the stability program
* Actively involved in Investigations e.g. LIR's. etc..
* Logging of samples in LIMS
* Entering results on LIMS, checking results are within specification and also task approval.
* Ensure compliance with EHS at all times, actively participate in EHS activities.
* Perform routine instrument calibration checks at appropriate times.
* Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times.
* Completion of Documentation for Batch Release process.
* Assisting in the provision of trends, CPV etc..
* Assist in audits.
* Generation/ reporting of Key performance indicators for the group.
* Be proactive in approach planning for future and implement improvements in an effective manner.
* Develop areas of expertise in analytical testing in order to solve technical issues.
* Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.
* Interaction with other departments e.g. QA, BU, Sterility assurance etc.
* Keep colleagues informed of current issues and developments as appropriate.
* Assist in the training and up skilling of colleagues.
* Reasonable level of overtime will be required to facilitate the business needs.
* Liaising with internal and external customers e.g., planning/ QA/ BU etc.
* Carry out additional duties as deemed necessary by your Group Leader/ Supervisor.
Required Qualifications
* A third level Science Qualification or equivalent
* Basic pharmaceutical experience in a GMP regulated laboratory environment.
Desired Characteristics
* Strong oral and written communication skills. Ability to document, plan, market, and execute programs.
Inclusion and Diversity
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.
Behaviors
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Additional Information
Relocation Assistance Provided: No