Serologist I

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 6000 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

The Responsibilities

• Performing all manufacturing processes in accordance with GMPs SOPs 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 groups 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.

The Individual

Required:

• Bachelors 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).

Preferred:

• 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 training progression through assigned curriculum.

The Key Working Relationships

• Internal Partners: Strong working relationships with the sites Material Management Quality Upstream Formulation EHS Facilities Engineering Product Support are necessary to drive effective prioritization and collaboration to meet the needs of the business

• External Partners: Suppliers

The Work Environment

The work environment characteristics are representative of an office laboratory and manufacturing environment. Flexible work hours to meet project deadlines and support of operational goals. Position requires ability to flexibly spend time on the desk analyzing data in meetings as well as hand-on product testing as needed. Specific vision abilities required by this job include close and distance vision and the ability to adjust focus. Position requires use of Personal Protective Equipment as posted.

Physical Demands

Manual dexterity to handle instruments complete repetitive motions and stand for long periods of time is required. Including sitting standing walking bending squatting balancing (Maintaining body equilibrium to prevent falling when walking standing or crouching on narrow slippery or erratically moving surfaces. Amount and kind of balancing exceeds that needed for ordinary locomotion and maintenance of body equilibrium) and ability to lift up to 30lbs.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals including individuals with disabilities have an opportunity to apply for those positions that they are interested in and qualify for without regard to race religion color national origin citizenship sex sexual orientation gender identity age veteran status disability genetic information or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform the duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability please contact us at .

#LI-SP1