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 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 Raritan New Jersey.

Work Schedule: First Shift 7:00am to 3:30pm

The 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.

​The IndividualRequired:

• 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). 

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 verbal6.Demonstrate training progression through assigned curriculum.

The Key Working Relationships

• Internal Partners: 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 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 $28/hour to $30/hour 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].