Serologist I

Micro Typing Systems•Pompano Beach, FL

33d•Onsite

About The Position

The Opportunity QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most - home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. he Role As we continue to grow, as one QuidelOrtho we are seeking a Serologist I to support our Immunohematology products. This person will be responsible for testing raw materials, in process bulk testing on Immunohematology products. This person will assure compliance with company standards and applicable regulatory agencies. You will be responsible to participate in failure investigations to help determine root cause, track and trend data, identify and suggest process improvements to improve business measures. This is an onsite position located in Pompano Beach Florida. Work Schedule: First Shift 7:00am to 3:30pm

Requirements

Bachelor's degree in Medical Technology, Biology or a related field of study and a minimum of 1-3 years' experience within a cGMP environment.
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).

Nice To Haves

Familiarity with the guidelines and regulations of FDA, OSHA, ISO and cGMP.
Good understanding of products and processes.
Strong mechanical and troubleshooting knowledge within area.
Attention to detail, documentation accurate and neat, must be very organized.
Interpersonal skills to include working independently or with a team member.
Excellent communication skills, both written and verbal6.Demonstrate training progression through assigned curriculum.

Responsibilities

Performing all manufacturing processes in accordance with GMP's, SOP's, TMs, safety rules and production schedule.
Use current documentation system as required.
Troubleshoot operational problems.
Works in an environment with ever-changing priorities.
Maintains accurate, complete and timely written batch records and documentation.
Perform batch record review of documents as needed.
Perform ERP transactions to ensure inventory is accurate.
Perform cycle counts and special counts in a timely manner.
Assure all raw materials are on-hand as needed for manufacturing processes.
Participate in group's compliance efforts regarding safety regulations and requirements including cGMPs, OSHA, Universal Precautions and Product License Agreements.
Clean and maintain production areas and equipment according to procedures.
Ensure equipment maintenance programs are followed, equipment is calibrated and scheduled preventative maintenance is performed when required.
Performs additional work-related duties as assigned.