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Quidel OPERATOR II, Assembly/Packaging in Raritan, New Jersey

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 Opportunity

As we continue to grow, we are seeking a Manufacturing Operator II. This position is responsible for performing manufacturing procedures and executing diverse tasks in manufacturing related to Donor Screening, Antisera and Red Cell processes in the Packaging manufacturing lines according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. Ensure materials are available to meet production schedule. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations. Accountable for adhering to all EHS guidelines.

This position is located in Raritan, NJ. This position is Monday-Friday, 6:00 am to 2:30pm.

The Responsibilities

  • Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.

  • Inspect products online to confirm proper assembly and remove defective products

  • Use of ERP system for performing material transactions/moves/quantities/cycle counts

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

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

  • Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations

  • Sets up and operates production equipment to produce work in process and finished goods

  • Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.

  • Wear the appropriate PPE when working in manufacturing and other working environments.

  • May perform other duties as assigned.

Additional Responsibilities:

  • Offer suggestions and follow up on process improvements related to safety, compliance, cost, yield and productivity.

  • Carry out duties in compliance with all state and federal regulations and guidelines including FDA, TUV, EPA and OSHA.

  • Adhere to the safety code of Conduct & EHS policies and attend all required EHS training.

  • Follow Global Leadership Profile (GLP) competencies based on their leadership level within the organization (individual leader)

Support the ongoing production schedule by:

  • Report to work on-time and according to the shift schedule.

  • Perform other duties as assigned.

  • Attend departmental and other scheduled meetings.

  • Practice good interpersonal and communication skills.

  • Demonstrate positive team-oriented approach in the daily execution of procedures.

  • Promote and work within a team environment

  • Learn new skills, procedures and processes as assigned by management and continue to develop professionally.

  • Assist with validation activities in the area

The Individual

  • 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience

  • High School diploma required.

  • Basic understanding and working knowledge of systems as required.

  • Ability to utilize tools within MS Office and other systems to improve business effectiveness.

  • Accurate Data Entry skills in ERP system

  • Ability to read, write and speak English

  • Read and interpret documents such as safety rules, operating instructions and logbooks

  • Review and provide feedback for SOP and Batch Record Revisions

  • Good communication and written skills

  • Is frequently required to communicate with coworkers.

  • While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms for extended periods of time.

  • Must pass vision acuity test for inspection of work in process and finished goods

  • Ability to lift up to 40 lbs.

  • Work with blood, blood products and chemicals

  • Overtime is required, as necessary

  • Shift work may be required, as necessary

  • Periodic exposure to 2-8C temperature controlled coldbox during product transfer.

The Key Working Relationships

Internal Partners: Equipment Manufacturing Operators, Quality Engineers, Field Engineers, Customer Service, Warehouse personnel

External Partners: Material Suppliers and Customers

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment and include the ability to stand and walk for long periods of time and be able to lift 75lbs. Regularly disassembling laboratory equipment, cleaning it per validated process and reassembling accordingly. May occasionally handle chemicals for use in final release testing of laboratory analyzers to customers.

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 $42,000.00 - $71,000.00 USD . 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 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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Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, p regnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law

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