Cleanroom Lead

Advita Ortho•Gainesville, FL

21d•Onsite

About The Position

To assist the Supervisor Packaging in supporting company objectives to meet or exceed the needs of our internal and external customers by meeting production goals and ensuring that all quality, compliance, and safety objectives are met. This person will support other packaging employees in managing resources responsibly, efficiently, and safely.

Requirements

High School Diploma or GED required.
3 years experience in medical device operations preferable
1 years experience in inventory control and MRP preferable
Experience with team leadership
Experience in cleanroom or other controlled operations.
Attention to detail
Record keeping skills
Experience in cleanroom or other controlled operations.
Proficient in windows based office productivity tools including word processor and spreadsheet
Experience in inventory control preferable
Excellent interpersonal relationship skills.

Responsibilities

Support the engagement and positive work environment for all Packaging Controlled Environment employees.
Assist Supervisor Packaging with evaluation of employees who support the Controlled environment.
Oversee Controlled environment for safe work practices. Elevate and coordinate with Safety Manager as needed
Know and comply with all department safety policies and procedures.
Perform process observations for training sign off and performance maintenance to ensure that all floor operators are processing per procedure
Support all CAPA/NC activity within the Packaging Controlled environment (Ultrasonic, Cleanroom, Burst Testing, Cleaning (inclusive of “Blue Zone” cleaning)
Coordinate cleaning and documentation of cleaning in the controlled areas.
Understand and follow all SOP for the Packaging Controlled Environment. All product or process non- conformances are documented and/or brought to the attention of the team leader or designee for disposition.
Know and apply the Quality System and any appropriate Federal and International Standards
Understand and train new employees or in Controlled Environment operations and process controls and/or develop new trainers.
Assist the Manager Packaging, Supervisor Packaging, and other lead people with workflow to meet production schedules and designate job assignments for packaging technicians.
Be able to perform or oversee any operation in the Packaging Controlled Environment.
Independently support cross functional work with Quality and Engineering often without the support or oversight of the Packaging Supervisor.
Assist and support other employees, teams and sales personnel as necessary.