Inter-departmental communication teamwork and strict compliance to all state/federal/local procedures and regulations.
Time management is critical due to the time sensitive nature of the radioactive products manufactured within a highly compliant (GMP) just-in-time manufacturing environment.
Act as an area or task leader reporting to the supervisor.
Process assemble dispense assay and package radio-chemicals radiopharmaceuticals or radioactive devices in accordance with established procedures.
Accurately review and complete all batch records and related documentation.
Preparation and set-up of associated equipment and materials
Comply with all applicable Environmental Health & Safety (EHS) Health Physics Quality System Requirements (QSRs) and Personal Protective Equipment (PPE) requirements.
Perform housekeeping in accordance with 5S policy.
Perform Preventative Maintenance (PM) as required.
Troubleshoot basic equipment problems by communicating with the supervisor and maintenance.
Assist authoring Change Records Deviations Investigation Reports (IRs) Corrective/Preventative Actions (CAPAs) and Unscheduled Work Orders (UWOs).
Utilize electronic database to track equipment maintenance and electronic system for web-controlled documents.
Ability to pass all gown qualifications associated with an ISO 5 or ISO 7 environment.
Required Qualifications:
Bachelors degree (or local equivalent) plus a minimum of 2 years of experience working in a healthcare or related cGMP manufacturing environment OR
Associates degree (or local equivalent) plus a minimum of 3 years of experience working in a healthcare or related cGMP manufacturing environment OR
High School diploma (or local equivalent) plus a minimum of 5 years working in a healthcare or cGMP-compliant manufacturing environment.
Basic computer/data entry skills.
Mathematical aptitude.
Able to perform shift/weekend work as required and allowed
Must be able to lift 35 lbs or more.
Desired Characteristics:
Associates degree (or greater) plus 5 years of experience working in a cGMP manufacturing environment.
Experience working with radioactive materials and/or radioactive isotopes.
Experience working with manufacturing equipment such as laminar low hoods autoclaves depyrogenation ovens isolators vaporized hydrogen peroxide (VHP) particle counters and other semi-automated equipment.
Experience with pharmaceutical formulation and fill/finish unit operations.
Experience with deviations/investigations/change management
Ability to multi-task.
Experience working with SAP TrackWise Veeva and ComplianceWire is a plus.
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.
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 youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
LI-MA4
We will not sponsor individuals for employment visas now or in the future for this job opening. For U.S. based positions only the pay range for this position is $50864.00-$76296.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills qualifications experience and addition this position may also be eligible to earn performance based incentive compensation which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package including not but limited to medical dental vision paid time off a 401(k) plan with employee and company contribution opportunities life disability and accident insurance and tuition reimbursement.GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual Opportunity Employer. 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
GE HealthCare provides digital infrastructure, data analytics & decision support tools helps in diagnosis, treatment and monitoring of patients