Operations Associate - CleanPac

The Operations Associate supports cleanroom operations, policies, and procedures, ensuring regulatory compliance. This role involves maintaining product integrity, traceability, and proper labeling/packaging through accurate documentation. Tasks include operating automated machinery, product assembly, preventative maintenance, and cleanroom monitoring. The associate will also assist in troubleshooting and inventory control, while adhering to quality management systems and safety standards.

Must Have

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations
• Operate process equipment such as automated machinery, measurement tools, and label printers
• Perform assembly and packaging of medical devices
• Maintain product integrity and traceability through proper documentation of Manufacturing Orders
• Adhere to the Quality Management System and support all quality initiatives
• Maintain regulatory batch records for operational tasks and assigned equipment
• Detail-oriented, able to follow directions and adhere to work instructions and procedures
• Ability to complete tasks independently without constant supervision
• Experience with Microsoft Office Suite, including Excel
• Ability to work in a cleanroom environment utilizing required garments and PPE

Good to Have

• Minimum 2 years’ experience in a production or shop environment
• Medical Device manufacturing experience
• Cleanroom manufacturing experience

Perks & Benefits

• 2 comprehensive medical plan options
• Flexible Spending Account or HSA Account
• Vision Benefits
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social events for employees and family

##### Operations Associate - CleanPac

Corporate - CleanPac

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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 hire
• Flexible Spending Account or HSA Account available
• Vision Benefits
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Paid Parental Leave
• Casual Dress Code
• Social 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.

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