Manufacturing Operator II

QuidelOrtho; Raritan (NJ); On-site; USD 44,000 - 61,000; Full time

Job summary

A leading company in the diagnostics field is seeking a Manufacturing Operator II in Raritan, NJ. This role involves operating production equipment, ensuring compliance with regulations, and maintaining quality standards. Candidates should have a high school diploma and experience in manufacturing or pharmaceuticals. Join a team that prioritizes employee happiness and engagement while contributing to a healthier future.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Employee Stock Purchase Plan

Paid Time Off

Paid Holidays

Qualifications

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

Responsibilities

• Execute manufacturing processes according to standard operating procedures.
• Inspect products on line to confirm proper assembly.
• Accurately complete documentation in batch records.

Skills

Organizational Skills

Communication

Education

High School diploma

Tools

MS Word

Excel

Job description

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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 the company continues to grow, we are seeking a Manufacturing Support Operator II in the Fill/Label area. This position is responsible for running the Lydon Oven, Getinge Autoclave, and Penntech Vial Washer and ensuring production materials are available. Additional tasks include supporting diverse tasks in manufacturing related to Donor Screening, Antisera and Red Cell processes in the Fill/Label manufacturing lines according to detailed operational specifications and execution of scheduled tasks within a cGMP environment. 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 in Raritan, NJ.

Schedule: Monday – Friday from 6:00am to 2:30pm. Overtime and shift work is required, as necessary.

The Responsibilities

1. Execute manufacturing or manufacturing-support processes according to standard operating procedures and current curriculum.
2. Inspect products on line to confirm proper assembly and remove defective products.
3. Accurately complete documentation in batch records, logbooks, forms and other GMP documents.
4. Verify and enter production parameters per SOP and Batch Records.
5. Use of ERP system for performing material transactions/moves/quantities/cycle counts.
6. Maintain working knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.
7. Sets up and operates production equipment to produce work in process and finished goods.
8. Assure manufacturing facility and equipment meets all requirements prior to production on all shifts.
9. Work with Shift Leader/Supervisor to review departmental production schedules, work orders and related information to ensure materials are available for production.
10. Compliance to safety, cGMP, ISO14001, and ISO9001 regulations and ability to identify nonconformances.
11. Wear the appropriate PPE when working in manufacturing and other working environments.
12. Demonstrate training progression, train designated personnel in all levels of responsibility.
13. 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.
14. Ability to read, write and speak English. Add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions, and decimals.

The Individual

Required

• High School diploma.
• Minimum of 2-4 Years MD&D/Pharmaceutical experience or equivalent industry experience.

Preferred

• Ability to write legibly, perform general math (add, subtract, multiply and divide) and have strong organizational skills.
• Work with blood, and blood products.
• Familiarity with 21CFR Part 820 (FDA Regulations), cGMPs, ISO 9001 standards and EHS Management System.
• Ability to effectively communicate, demonstrate a sense of urgency, and responsibility for the quality and timeliness of work.
• Ability to work independently and in a cross-functional team environment.
• Knowledge of Quality Information Systems (Windchill).
• Computer literacy with ability to use MS Word and Excel.

The Key Working Relationships

• Internal Partners: Planning, QA, QC Inspection, Quality Engineering, Warehouse personnel, Manufacturing and Facilities
• External Partners: Material Suppliers and Customers

The Work Environment

The work environment characteristics are representative of a manufacturing, laboratory, or warehouse environment. 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. Is frequently required to communicate with coworkers. Ability to lift-up to 40lbs. Work with blood, blood products and chemicals. Overtime is required, as necessary. Shift work may be required, as necessary. Periodic exposure to 2-8°C temperature controlled cold box during product transfer.

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 $44,000 to $61,000 and is eligible for QuidelOrtho's bonus plan. 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 [e-mail].

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Management and Manufacturing
• Industries
• Medical Equipment Manufacturing

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