GE HealthCare QC Finish Product Analyst – Shift 

Ireland, Cork 

249667737

Job Description SummaryCarry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that batch release turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume, particulate matter, complaints and any other tests required etc.Responsibilities

• Carry out routine analysis on Finished Product samples ensuring compliance with cGLP/cGMP and that batch release turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodine, Thin Layer Chromatography, Free aromatic amines, pH, RI, Trom’s, EDTA, Technical tests, Extractable volume, particulate matter, complaints and any other tests required etc.

• Assisting in the maintenance of the stability program including testing for same.

• Actively involved in Laboratory Investigations e.g. OOSs etc.

• Logging of samples in LIMS.

• Entering results on LIMS, checking results are within specification and performing task approval.

• Always ensuring compliance with EHS, actively participate in EHS activities onsite and across the QC Department.

• Perform routine instrument calibration checks at appropriate times.

• Preparation and control of Standard Operating Procedures and always ensuring compliance with cGMP guidelines.

• Completion of documentation for batch release process.

• Assisting in the generation of trends such as CPV etc.

• Assisting in internal and external audits.

• Support the sustainment of 5S certification within the lab and the wider QC Department through routine audits.

• Generation/ reporting of key performance indicators for the group.

• Develop areas of expertise in analytical testing to solve technical issues.

• Ensure compliance with current pharmacopoeias and all regulatory/company guidelines.

• Interaction with other departments e.g. QA, Production, Sterility assurance etc.

• Keep colleagues informed of current issues and developments as appropriate.

• Assist in the training and up skilling of colleagues.

• Liaising with internal and external customers e.g., planning/ QA/ Production etc.

• Be proactive in approach planning for future and implement improvements in an effective manner.

• Supporting the lab consumable management programme.

• Carry out any additional duties as deemed necessary by your Senior analyst/ People Team Lead.

• Reasonable level of overtime may be required to facilitate the business needs.

Required Qualifications

• A third level Science Qualification

• Basic pharmaceutical experience in a GMP regulated laboratory environment.

Desired Qualifications

• Basic pharmaceutical experience in a GMP regulated laboratory environment.

• Strong oral and written communication skills.

• Excellent time management skills. Flexibility and agility will be required.

• Openness to change. Proven ability to work on own initiative and deliver expectations.

Inclusion and Diversity

Total RewardsOur 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.