Job Title: Pharma Manufacturing Technician 1
location: South Plainfield, NJ
Duration: 12 months
1. Inter-departmental communication, teamwork and strict compliance to all state/federal/local procedures and regulations are critical due to the time-sensitive nature of the radioactive products manufactured within this highly compliant, just-in-time manufacturing environment.
2. Process, assemble, dispense, assay and package radio chemicals, radiopharmaceuticals or radioactive devices in accordance with established procedures.
3. Accurately review and complete all batch records and related documentation.
4. Preparation and set-up of associated equipment and materials, i.e. ion chambers, autoclaves, etc.
5. Comply with all applicable Environmental Health & Safety (EHS), Health Physics, Quality System Requirements (QSR’s) and Personal Protective Equipment (PPE) requirements.
6. Strict adherence to cGMP always.
7. Perform housekeeping in accordance with 5S policy.
8. Perform Preventative Maintenance (PMs) as required / assigned.
9. Troubleshoot basic equipment problems by communicating with SME.
10. Assist in writing Investigation Reports (IR’s) and Unscheduled Work Orders (UWO’s).
11. Utilize Trackwise program / and internal document control program.
12. Ability to pass all gown qualifications is required for employees who need to perform work in the dilution and filling suite.
Quality Specific Goals:
1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
2. Complete all planned Quality & Compliance training within the defined deadlines
3. Identify and report any quality or compliance concerns and take immediate corrective action as required
1. Associate’s degree (or local equivalent) plus a minimum of 3 months’ experience working in a healthcare or related manufacturing environment; or High School diploma/ equivalent plus a minimum of 1 year working in a healthcare or related manufacturing environment.
2. Basic computer/data entry skills.
3. Mathematical aptitude.
4. Must understand oral/written technical English (or local language).
5. Able to perform shift/weekend work as required and allowed
6. Must be able to lift 35 lbs. or more.
1. Associates degree plus 2 years’ experience working in a cGMP manufacturing environment.
2. Experience working with radioactive materials and/or radioactive isotopes.
3. Experience working with Access database programs and manufacturing equipment such as ion chambers, autoclaves, pyrogen ovens, counters, micro welders and semi-automated equipment.
4. Previous experience in roles requiring strong attention to detail.
5. Ability to multi-task.