Hybrid QA Technical Specialist

at BD

• Job title: QA Technical Specialist
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: High School Diploma
• Location requirements: Hybrid, Madison, United States

About the role

• QA Technical Specialist providing sterilization technical support for BD Business Units. Ensuring compliance and maintaining QA technical applications related to EO sterilization and validation.

Responsibilities

• The QA Technical Specialist is responsible for providing sterilization technical support for the sterilization group in conducting the validation activities for all BD Business Units whose product is sterilized by BD Interventional Sterilization as required.
• Support BD facilities / Business Units in sterilization validations and product launch activities by providing monitoring equipment and technical support.
• Maintains calibration and routine maintenance of the validation temp/RH monitoring equipment.
• Ensures compliance to divisional, Corporate, ISO, and EN requirements.
• Provides technical support for routine EO environmental safety programs including personnel monitoring and facility Baseline system.
• Writes all applicable protocols, reports, and procedures to support the QA technical applications to include Rotronics and QA projects as assigned.
• Assist QA Management in performing failure investigations.
• Revise and/or develop SOPs to support sterilization program.
• Support cost savings programs.
• Verifies DHR documents for accuracy and completeness prior to product release, when necessary.

Requirements

• High School graduate (Associates or Bachelor's degree preferred)
• Preferred three years of experience in medical device or GMP regulated environment with process validation of medical devices, pharmaceuticals or biologics.
• Must possess the ability to work independently.
• Must be detailed oriented.
• Must possess knowledge about the physical, chemical, and biological sciences.
• Must understand impact of environmental control, packaging, and manufacturing process on sterility assurance.
• Thorough understanding of EO sterilization/validation.
• Have an understanding of process and equipment validation methodology with technical writing skills.
• Must be current on government regulations and international regulations regarding the sterilization of medical devices.
• Knowledge of hazardous chemical awareness.
• Proficient in the use of a personal computer with intermediate level of keyboarding skills with knowledge of Microsoft Word, Excel, and Access.
• Strong interpersonal skills required in the areas of verbal and written communications, customer focus, professionalism, telephone courtesy, influencing, and team building.

Benefits

• Health insurance
• Retirement plans
• Paid time off
• Flexible working arrangements
• Professional development opportunities