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QC Serologist
Ref No.: 18-00706
Location: Raritan, New Jersey
Start Date / End Date: 05/14/2018 to 05/31/2019

We are seeking a QC Serologist, preferably with blood banking experience, who will be responsible for performing in-process testing. This person will assure compliance with company standards and applicable regulatory agencies.

He/She will participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures. The Serologist I will perform testing within established timelines in accordance with current cGMP's.

He/She 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 Serologist I will document results clearly and accurately as well as be able to interpret results by comparing results against appropriate specification requirements.

He/She will perform data entry of critical product/process information and test results to be used in trend analysis.

He/She will maintain work areas and equipment as well as ensure calibration and maintenance of equipment are performed at designated intervals. The successful candidate will adhere to departmental and Clients 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.

He/She will be accountable for reporting nonconformance's to management immediately. 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 Serologist I will be familiar with 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 a 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.

REQUIREMENTS

  • A Bachelor's degree in Medical Technology, Biology, Chemistry or a related field of study and a minimum of 1-3 years' experience with QC, GMP, and analytical procedures is required.
  • Experience with analytical instrumentation such as AutoVue and ProVue 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.
  • Blood banking experience a plus.
  • 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 position is located in Raritan, NJ. You must be able to work the following hours 6:30AM-6:30PM and have the flexibility to work other shifts when necessary. Weekends and overtime are required.
  • This is a DAY shift position - hours 6AM to 6PM on a 12-hour rotating shift - 6AM - 6PM (Monday, Tuesday, Saturday, Sunday one week than Wednesday, Thursday, Friday the next week, then repeat.)