Staff Regulatory Affairs Specialist - Hybrid

Job Description Summary

This position is responsible for performing chemical testing, test reporting, and procedure training. Also works independently on assigned projects interfacing with supervisor as required. Provides technical expertise and develops test methods and protocols. Serves as alternate in the absence of the Laboratory Supervisor.

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

• Major lab functions as assigned: QA testing, special projects, product EtO residual program, and technician training program.

• Evaluation, development, and/or revising of test methods.

• Qualification/validation of new test methods, instruments, and computer programs.

• Writing of instrumentation operating, calibration, and maintenance procedures as well as troubleshooting as required.

• Development and implementation of laboratory training procedures.

• Supporting laboratory testing as required.

• Coordination of testing, development of protocols, writing of test summaries and reports associated with special testing projects.

• Supervising technicians as assigned.

• Assisting laboratory supervisor in budget responsibilities.

• Performing as acting supervisor in the absence of the Laboratory Supervisor.

• Compliance with all laboratory and company operating and safety policies and requirements.

• Good understanding of OSHA requirements, QSRs, GLPs, ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential 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 be able to work independently with very little direct supervision.

• Must be knowledgeable in wet bench chemistry techniques including standard analytical test methods (e.g., ACS, USP, ASTM, etc.).

• Must have working knowledge of standard analytical equipment and functions: pH meter, conductivity meter, TOC, viscometers, analytical balances, titration, etc.

• Must have working knowledge of chromatographic and spectrophotometric instrumentation used in the laboratory, including GC, AA, UV/VIS, FT-IR, and FT-IR Microscope.

• Must have working knowledge of Mass Spectrometry equipment used in the laboratory including GC-MS, and ICP-MS.

• Must have working knowledge of standard computer programs (Excel, Word, etc.)

• Must have understanding and be able to utilize basic statistics.

• Must have good organizational skills; be able to organize and complete work in a timely manner.

EDUCATION and/or EXPERIENCE

• B.S. degree in chemistry or equivalent from a four-year college or university

• Three (3) or more years of laboratory experience.

LANGUAGE SKILLS

• Must have good oral and written communication skills.

• Ability to read, write, and comprehend instructions and correspondence.

• Must be able to effectively present technical information in one-on-one and small group situations with customers, clients, and other employees within the organization.

MATHEMATICAL SKILLS

• Entry-level college algebra, general mathematics, and statistics are used routinely in day-to-day operations.

REASONING ABILITY

• Must be able to interpret technical reports.

• Must use sound judgment when interpreting such reports in order to make accurate assessments of acceptance.

PHYSICAL DEMANDS

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to sit, stand, talk, and hear.

• The employee is frequently required to use hands/fingers to handle and/or feel.

• The employee is occasionally required to stand and reach with hands and arms, and lifts and/or moves up to fifty pounds.

WORK ENVIRONMENT

• The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Work environment requires handling of all types of chemicals including those that present health, flammability, and reactivity hazards.

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/Affirmative Action Employer. We do not unlawfully discriminate on the basis of 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, or any other protected status.

PDN

Primary Work Location

USA GA - Covington BMD

Additional Locations

Work Shift