QA Technical Specialist
Onsite, Multiple Locations
Job Description Summary
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.
We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you’ll be supported to learn, grow and become your best self. Become a maker of possible with us.
JOB OVERVIEW
The QA Technical Specialist is responsible for providing sterilization technical support for thesterilizationgroupinconducting thevalidation activitiesforallBD Business Units whoseproduct issterilized by BD Interventional Sterilization as required. The QA Technical Specialist will support technical QA projects with execution and protocol/report writing as assigned. This position will support the routine monitoring equipment for EO Environmental programs and provide technical oversight of the equipment calibration program and document control in the Madison facility.Thisposition willassistinreviewandassemblingofsterilization DHRs for product release when necessary.
ESSENTIAL DUTIES AND Responsibilities
including the following. Other duties may be assigned.
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.
QUALIFICATIONS
Toperformthisjobsuccessfully,anindividual mustbeabletoperform eachessential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
ThoroughunderstandingofEOsterilization/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.
Forklift experience is preferred
EDUCATION and/or EXPERIENCE
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.
LANGUAGE SKILLS
Excellent written and verbal communication skills. Ability to prepare technical reports and write technical procedures.
Ability to communicate ideas articulately.
MATHEMATICAL SKILLS
Ability to apply mathematical concepts such as algebra, calculus, and statistics.
REASONING ABILITY
Ability to effectively manage day to day decisions concerning sterilization projects.
Ability to interpret and implement internal, domestic, and international guidelines within the limits of the organization. Judgment is essential.
Determining what is absolutely vital and ensuring compliance with limited parameters is imperative.
A high level of initiative is required. Day-to-day decisions about projects and validation programs are made frequently.
Position will collaborate with internal and other division employees, contractors, and· regulatory agencies.
PHYSICAL DEMANDS
This position entails regular sitting, object manipulation, sensing, arm extension, and verbal communication.
Standing and walking are regular activities for the employee.
The employee is required to climb or balance and stoop, kneel, crouch or crawl.
Must be capable of lifting at least 25 pounds.
Specific vision abilities required by this job include close vision and distance vision.
WORK ENVIRONMENT
This position works in a normal office environment.
The noise level in the work environment is quiet to moderate.
Occasionally, the employee will be in hot and humid conditions, near moving mechanical parts, work in high precarious places, or have the potential to be exposed to toxic or caustic chemicals.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company’s receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD’s Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It’s also a place where we help each other be great, we do what’s right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you’ll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics.
#earlycareer
Required Skills
Optional Skills
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Primary Work Location
USA GA - MadisonAdditional Locations
USA GA - Covington BMDWork Shift
People here are amazing, and their passion for what they do comes through in everything they do.
Wendoly LaVolpe
Employer Brand Manager NA & LATAMs
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