The Operations Associate will support proper cleanroom operations, policies, procedures, and work instructions. This role must maintain and ensure Regulatory Compliance in every work task. This position is primarily responsible for ensuring product integrity, traceability and proper labeling and packaging through the accurate documentation of each aspect of their job function. Tasks may include operating automated machinery, product assembly, preventative maintenance, and cleanroom monitoring. Other duties may develop over time based on business needs and availability. 

Essential Duties and Responsibilities:

Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations.Operate process equipment, such as automated machinery, measurement tools, label printers, etc.Perform assembly and packaging of medical devices.Maintain product integrity and traceability through proper documentation of Manufacturing Orders.  Perform and be actively engaged in shutdowns, and other events that adversely affect operational status.Assist engineering team in troubleshooting efforts and other tasks that affect operations.Maintain a Safe work environment and adherence to regulated products in a regulated environment. Adhere to the Quality Management System and support all quality initiatives.Maintain regulatory batch records as required for each operational task and assigned equipment.Assist in cleanroom inventory control as necessary. 

 

Qualifications:

Must be detail oriented, able to follow directions and adhere to work instructions and procedures in a structured work environment.Ability to complete tasks independently without constant supervision.Experience with Microsoft Office Suite Required including Excel. Must be able to work in a cleanroom environment utilizing required garments and PPE.

 

Education:

High School Diploma and/or combination of experience.Minimum 2 years’ experience in a production or shop environment is preferred.Medical Device manufacturing preferred.Cleanroom manufacturing experience preferred.

Benefits:

 

2 comprehensive medical plan options to choose from available the first of each month following your date of hireFlexible Spending Account or HSA Account availableVision BenefitsCompany paid Dental Insurance for employee and dependentsWellness Plan401k with 5% matchingGenerous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service HoursCompany paid Short Term DisabilityLong Term DisabilityCompany provided Life InsurancePaid Parental LeaveCasual Dress CodeSocial events for employees and family

 

 

Henry Schein, Inc.  is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

 

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.