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 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.

The Role

As we continue to grow, as one QuidelOrtho we are seeking a Serologist I to work in our manufacturing facility in Raritan NJ. This Serologist I will perform manufacturing test methods and execute diverse tasks in association with the serological evaluation and determinate of biological raw material, in processing blood bank reagents and blood screening reagents according to detailed operational specifications and execute scheduled tasks within a CGMP environment. They will ensure materials are available to meet the production schedule and have responsibility for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. This position is located in Raritan, NJ.

Schedule: 7:00 am – 3:30 pm Monday – Friday.

The Responsibilities

• Perform and understand detailed test methods and procedures to include: serological evaluation (antigen typing) of blood and blood products using traditional tube test methods and Column Agglutination Technology (CAT).

• Perform in-process testing as required by processes and procedures utilizing equipment/instrumentation, such as microscope, calibrated pipettes, centrifuge, incubator, water bath. This list is not all inclusive

• Knowledge and understanding of test methods and interpretation of test results

• Verify and enter production parameters per SOP and Batch Records.

• Accurately complete documentation in batch records, logbooks, systems, forms and other GMP documents.

• Maintain supplies and test reagent inventory.

• Operate and troubleshoot equipment in a non-clean room environment.

• Monitor environmental conditions in non-clean room environment.

• Use of ERP system for performing material transactions/moves/quantities/cycle counts/scrap/usage decisions. Use of System to perform data input and investigations.

• Support investigations and projects

• Proactively maintain a clean and safe work environment by performing sanitizing and housekeeping duties and looks for opportunities to improve. Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.

• Review and revise BTRs, SOPs, etc. for accuracy

• Quality and Regulatory Compliance including (1) reviews and resolutions of non-conformances, (2) audit preparation and participation and (3) understanding and utilization of the Quality Management systems to support production compliance.

• Performs additional work-related duties as assigned.

The Individual

Required:

• Bachelor’s degree in medical technology, Biology, Biochemistry or related field.

• 1 year of related experience. 

• Knowledge of Immunohematology theory and practice.

• Strong written and verbal communication skills.

• Strong computer Skills (MS Office and documentation systems)

• Strong analytical skills

• Ability to lift 35 pounds

• Mechanical aptitude and competence

• Knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.

• Ability to work overtime as necessary.

Preferred:

• Bachelors degree in Medical Technology.

• Diagnostics or Pharmaceutical experience.

• Hospital Blood Bank/Donor Center or equivalent regulated industry experience.

The Key Working Relationships

• Internal Partners: Product Support/R&D, Manufacturing, Quality Assurance, Materials Management, Technical Support, Engineering and Commercial.

• 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.

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $57,000 to $70,000 annually and is eligible a bonus. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

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 [email protected].