BD (Becton, Dickinson and Company) Compliance Specialist in Grayson, Georgia
Job Description Summary
The Quality Systems Specialist is responsible for assuring FDA / ISO Compliance activities are recognized, prioritized, and completed in an accurate and timely manner. This is a key compliance role and will interface directly with regulatory authorities and other BDX sites
Must be able to work independently, with little or no supervision, and prioritize daily work load based on business needs. Must possess good written and verbal communication skills, be analytical, detail oriented, and able to handle constantly changing priorities.
Be Part of Something Bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics, and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Duties and Responsibilities:
CAPA Coordinator – 15%:
Performs risk assessment on potential issues to determine if a CAPA is needed.
Assigns CAPA. Tracks and monitor ongoing CAPA to assure completion dates are met.
Meets with investigators, assists in designing experiments. Documents activities.
Risk Management – 20%
Create and update risk management for the product lines for the site.
Work with BD Regulatory Affairs to develop strategies for compliance
Change control – 15%
Documents changes according to procedure.
Monitors ongoing changes to assure timeliness of completion.
Assures all affected areas are aware of the change.
Complaint handling – 20%
Assign complaint investigations, testing product or arranging for testing, and providing thorough documented results.
Track and trend complaint data to investigate for potential corrective and preventive actions.
Accurately create reports to local and Global Quality groups.
Internal auditing – 10%
Schedule the Grayson site internal audit program to assure all areas are audited according to schedule.
Completes audits and records data.
Tracks and trends audit ANRs and suggestions improvement to compliance program.
Develop ideas that will continuously improve the company’s systems and/or products through corrective actions and preventive actions. Developing the actions needed and driving the changes through to completion.
Meet with regulatory authorities and serve as a QA liaison during external audits of the facility.
Other activities – 15%
Stability Coordinator - assign stability studies and arranges for samples and testing. Reports data.
Reviews animal origin information
Become a team member on special projects.
Cross train and become proficient in product testing as needed.
Knowledge and Skills:
Expertise with Microsoft applications (Word, PowerPoint, Excel, Outlook)
Effective organization, planning, and interpersonal skills
Capable of readily identifying, analyzing problems and develop/present recommended solutions
Strong demonstrated analytical skills using databases and statistical software
Excellent communication skills and demonstrated ability to participate in problem solving and problem identification.
Education and Experience:
Bachelor’s Degree education.
Preferred two 2 years experience in an ISO and GMP scientific or technical environment. Lab / testing experience can be considered as part of this requirement in combination.
Preferred 2 years of Practical Knowledge of the application of FDA’s Quality System Regulations and ISO 13485 requirements. Lab / testing experience can be considered as part of this requirement in combination.
Demonstrated ability to work effectively in a team based environment.
Ability to communicate clearly and effectively (verbally and written) with all levels within and outside the organization.
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 empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson, and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on 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.
Primary Work Location
USA GA - Grayson
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.