BD (Becton, Dickinson and Company) Documentation Control Analyst in Covington, Georgia
BD UCC is a Becton-Dickinson Company. We are seeking to fill the position of Documentation Control Analyst based in Covington, Georgia.
The Documentation Control Analyst has responsibility for assisting with administration of controlled document activity in the Quality Assurance Document Control department.
This position is responsible for data analysis, design and creation of reports related to document and change control. This position includes additional duties in support of document control and Project/Design Control and change control systems, and implementation of the electronic documentation and change control system.
Reviews and analyzes proposed changes to controlled documentation.
Interacts with data management systems and recognizes system’s events outside the norm.
Performs training in Document Control procedures.
Implementation of documentation and change control using the electronic documentation and change control software, including validation and auditing activities.
Assesses current system and processes and recommends improvements.
Participates in investigations, audits and on cross-functional teams.
Assist with programming or configuring systems to meet business needs as applicable.
Writes, reviews and executes documents.
Generates Quality reports as required.
Responsible for maintaining / updating QA hold spreadsheet in Master Control for all division distribution holds. Also responsible for issuing BMD product holds.
Responsible for issuance of document numbers in JDE system; review/issuance of waivers and for department monthly metrics.
Knowledge and proficiency in the use of MasterControl or similar document control/change control software as a system administrator.
Knowledge and proficiency in application of Quality System Requirements (QSR) and ISO13485 required.
Working knowledge of document control, device master records and change control.
Knowledge and understanding of FDA regulations and ISO standards related to controlled documentation.
Knowledge and proficiency in the use a personal computer and of Microsoft Word, Access, Excel, PowerPoint and Crystal Reports software.
Ability to interpret regulations, corporate, division and department procedures.
Ability to collect and analyze data.
Ability to exercise tact, maturity and judgment when dealing with employees and visitors.
Strong interpersonal skills required in the areas of verbal and written communications, employee focus, service to internal customers, telephone courtesy, professionalism, coaching, influencing, training and team building.
Strong listening, assessment, questioning and problem-solving skills.
Ability to manage time and multiple tasks in an organized manner.
Ability to work with minimal supervision.
Basic understanding of auditing principles.
Ability to participate on teams and maintain positive work environment with those teams.
Excellent oral and written communication skills in English are required, with abilities in Spanish a desirable additional skill. Ability to read and comprehend instructions, correspondence, reports regulations and memos. Ability to write reports and formal correspondence. Ability to effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to create and interpret graphical analysis of data.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
Bachelors’ degree (B.A./B.S.) from four-year college or university required.
Three (3) plus years of related experience working with controlled documents or data management within an FDA or other regulated industry required.
Internal/external auditing experience a plus.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee is occasionally required to stand and reach with hands and arms and lifts and/or moves up to ten pounds. Employee is required to meet with other personnel in other areas of building. Specific vision abilities required by this job include close vision and ability to read a computer monitor.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate. #LI-CW1
Industry Standard/Category: Documentation Control Analyst/Quality Systems
Career Level: experienced
Division Name: Bard Medical Division
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.