Scientist II (Donor Screening)

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.

As we continue to grow, we're seeking a Scientist II to join our Donor Screening operations. This position is primarily responsible for testing microplates that are coated with Antigens, formulation and in-process testing of reagents, conjugates and controls for Donor Screening Kit Components according to established procedures or approved protocols. Need to be familiar with multiple testing / formulation labs in Donor Screening Area.

Donor Screening Kit for ELISA Test System includes the following seven components that are product-specific: positive control, negative control, conjugate-antibody, antigen-coated microwell plates, specimen diluent, substrate buffer and o-phenylenediamine 2-HCl tablets. This results in common manufacturing sub-process steps that include formulation of multiple bulks and antigen-coated microplate process.

It includes receipt and inspection of incoming raw materials, microplate coating and testing, formulation and in-process testing of reagents, conjugates and controls, filtration and filling of bulks, and release testing followed by kit packaging. Manufactured finished goods are released on acceptable in-process, QA release testing along with concurrent CBER lot release according to set specifications.

This position is located onsite in Raritan, NJ.

• Perform all manufacturing processes in accordance with GMP's, SOP's, TMs, safety rules and production schedule. Assist in the manufacture and qualification of In-House panels. 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.

• 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.

• 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.

• Perform other work-related duties as assigned.

• Bachelor's Degree in a Scientific field with 3+ years of experience at a medical or manufacturing facility; or equivalent combination of education and experience.

• Ability to demonstrate flexibility and adaptability; ability to prioritize within a changing business environment.

• Demonstrates an attention detail; ability to stay focused on the task at hand for long periods of time.

• Ability to effectively communicate; demonstrate a sense of urgency to complete production schedule on time; accepts personal responsibility for the quality and timeliness of work.

• Basic computer skills i.e. Microsoft Office (Word, Excel, Outlook).

• Ability to work both independently and within a team environment.

• Good understanding of products and processes.

• Good knowledge of Biology, Chemistry, Biochemistry and Immunology theory and practice.

• Attention to detail, documentation accurate and neat, and be very organized.

• Interpersonal skills to include working independently or as a team member.

• Excellent communication skills, both written and verbal.

• This position is not currently eligible for visa sponsorship.

Internal - Strong working relationships with the site's 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 - External vendors brought on site for equipment changes/upgrades.

The work environment characteristics are representative of a manufacturing or laboratory environment. refrigerated temperature (2-8C) walk-in cold box around 15 minutes to formulate products and -20C walk-in freezer on very few occasions to quickly store or retrieve frozen items. Desk work in the cubicle, testing in the laboratory and formulation in refrigerated walk-in cold box. Handle biologic samples and require the use of PPEs (safety glasses, gloves, lab coats). May require overtime or weekend work when production issues arise

Position requires ability to sit, stand, walk, bend, squat, push and pull, repetitive movement (pipetting of samples).

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 $79,000 to $100,000. 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.

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 their 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 recruiting@quidelortho.com.

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