Operations Associate - CleanPac

BioHorizons; Birmingham (AL); On-site; USD 38,000 - 48,000; Full time

Benefits offered by this job

Medical plans

FSA/HSA

Vision benefits

Dental insurance

Wellness plan

401k 5% match

Generous PTO with holidays

Short term disability

Long term disability

Life insurance

Parental leave

Casual dress code

Social events

Job summary

BioHorizons in Birmingham, AL is seeking an Operations Associate to support cleanroom operations, labeling and packaging, and maintain regulatory compliance through accurate documentation.

Responsibilities include operating automated machinery, assembling medical devices, performing routine cleanroom tasks, assisting engineering in troubleshooting, and maintaining a safe GMP environment. Proficiency with Excel and attention to detail are required.

Qualifications

• Must be detail oriented and able to follow directions in a structured environment.
• Ability to work independently without constant supervision.
• Experience with Microsoft Office Suite including Excel.
• Must be able to work in a cleanroom environment with PPE.

Responsibilities

• Perform routine cleaning, maintenance, and monitoring of cleanroom and controlled area operations.
• Operate process equipment such as automated machinery and label printers.
• Assemble and package medical devices with proper documentation.
• Maintain product integrity and traceability through Manufacturing Orders.
• Support shutdowns and events affecting operations.
• Assist engineering with troubleshooting and other operations tasks.
• Maintain a safe, regulated work environment and comply with Quality Management System.
• Maintain regulatory batch records for tasks and equipment.
• Assist in cleanroom inventory control.

Skills

Detail oriented

Follow instructions

Independent work

Excel

Cleanroom PPE

Education

High School Diploma

Production experience preferred

Tools

Microsoft Office

Job description

Work Schedule: Monday - Thursday 10 hr. days

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.