Film Coating Operator II, III

The Opportunity

Quidel Ortho 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 as one Quidel Ortho we are seeking a Film Coating Operator - Multiple Levels to perform operations as described by our Standard Operating Procedures (SOPs) under Good Manufacturing Practices (GMPs) in our Film manufacturing Department located in Rochester, NY. You will prepare sets-ups and assemble components needed for production, visually inspect components for defects, operate and troubleshoot equipment issues while strictly following all regulations and requirements including cGMP's, OSHA, FDA, and ISO regulations.

This position is in Rochester, NY.

Schedule:

Must be available to work a flexible shift environment, including weekends, based on business needs. The schedule utilizes a bi-weekly rotation for primary shifts, with an overnight shift reserved for business-critical overtime.

A Shift (6:00 AM – 2:30 PM):
Part of the primary bi-weekly rotation. Employees work Shift A one week and alternate to Shift B the next.

B Shift (2:15 PM – 10:45 PM):
Part of the primary bi-weekly rotation (alternating weekly with Shift

A). This shift requires occasional mandatory overtime.

Straight C shift of 4 10hr shifts are M-Th 9:30pm-7:30am may also be available.

Level 2:
Film Coating Operator II

• Responsible for using equipment for the assembly and processing tasks to produce finished products according to established specifications.

• Accountable for adhering to all quality and safety guidelines.

• Effectively communicates verbally and in writing.

• Demonstrates a sense of urgency to complete production schedule on time.

• Accepts personal responsibility for the quality and timeliness of work.

• Accurately and timely completes all required reporting functions.

• Uses computer based documentation system to find, view and print specifications and procedures.

• Disposes of scrap/rejected material in appropriate manner and according to safety regulations.

• Clean and assemble equipment while following safety procedures and practices and maintaining a clean orderly work environment.

• Disposes of hazardous materials appropriately, operates machinery and interacts with computer controlled equipment and processes.

• Conducts basic quality inspection of work in accordance with statistical process or other control procedures.

• Participates in projects focused on process development and/or improvement, cost controls and new product manufacturing.

• Ability to work in a team environment.

• Perform other duties as assigned

Required:

• A High School Diploma or GED.

• Strong mechanical aptitude, troubleshooting of equipment.

• The ability to read and write in English.

• A minimum of 3 months experience in operations/manufacturing environment (prefer a regulated industry).

• Must have basic computer skills i.e. Microsoft Office (Word, Excel, outlook).

Preferred:

• Experience with quality information systems (i.e. SAP).

• Knowledge and experience with GMP/ISO regulations.

• Perform duties pertaining to Film Coating

• Effectively communicates verbally and in writing.

• Demonstrates a sense of urgency to complete production schedule on time.

• Accepts personal responsibility for the quality and timeliness of work.

• Accurately and timely completes all required reporting functions using an SAP/ERP computer system.

• Uses computer-based documentation system to find, view and print specifications and…