Category: Scientific & Clinical
Title: QC Serologist I
Location: Raritan, NJ
Schedule: 8am to 5pm Mon – Fri.
Start date: ASAP
- The QC Serologist I will be responsible for performing in-process and release testing of all types of BioVue cassettes and Gel Cards.
- This person will assure compliance with company standards and applicable regulatory agencies.
- The incumbent will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures.
- The QC Serologist I will perform testing within established timelines in accordance with current cGMP’s.
- The incumbent will participate in equipment maintenance/calibration program.
- The successful candidate will have the ability to prioritize and handle multiple tasks and challenges at one time and have the ability to work in a team environment and provide customer focused results in an efficient manner.
- The QC Serologist I will document results clearly and accurately as well as be able to interpret results by comparing results against appropriate specification requirements.
- The incumbent will perform data entry of critical product/process information and test results to be used in trend analysis.
- The incumbent will maintain work areas and equipment as well as ensure calibration and maintenance of equipment is performed at designated intervals.
- The successful candidate will adhere to departmental and Company SOP’s and safety requirements as well as be accountable for notifying management of any out of specifications or abnormal trend in results in a timely manner.
- The incumbent will be accountable for reporting nonconformance’s to management immediately.
- QC Serologist I provide support during regulatory inspections.
- Edits documentation (i.e. Standard Operating Procedures, test methods, batch records).
- Understands and applies PE tools in daily work activities.
- The QC Serologist I will be familiar with ORTHO safety and environmental policies and perform work tasks and operations in compliance with all safety and environmental rules and regulations, and encourage co-workers to do so; if uncertain, consults with supervisor.
- Attend applicable safety and environmental education and training programs and attend departmental safety and environmental meetings.
- Immediately report and correct, if possible, unsafe conditions, spills and near miss incidents.
- Conduct self-inspections of workstations and offices for hazardous conditions.
- All employees are required to cultivate an environment of quality & compliance in their actions.
This includes attending all required training, adhering to the processes & procedures of their role and the company and displaying the highest level of integrity.
- A Bachelor's degree in Medical Technology/Medical Laboratory Scientist, Biology and a minimum of 1-3 years’ experience with QC, GMP, and immunohematology procedures is required.
- Previous hospital and/or Blood Banking experience.
- Experience with analytical instrumentation such as ProVue, and/or Ortho VISION is preferred.
- Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP is preferred.
- Manual dexterity to handle instruments, complete repetitive motions, and stand for long periods of time is required. Diligent use of PPEs (Personal Protective Equipment) to limit exposure to bloodborne pathogens is required.
- Excellent oral and written communication skills are required.
- Proficiency with the Microsoft Office suite of products (Excel, Word, PowerPoint, Outlook).
- This is a day shift position and you must be able to work the following hours 6:30AM-6:30PM and have flexibility to work other shifts when necessary. Weekends and overtime are required.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.