BD (Becton, Dickinson and Company) Documentation Control Analyst in Covington, Georgia

Category: Documentation Control Analyst/Quality Systems

Job ID: 2018-11431

Career Level: experienced

Division: Bard Medical Division

Relocation: No

Location: Covington,Georgia,United States

Overview:

BD UCC is a Becton-Dickinson Company. We are seeking to fill the position of Documentation Control Analyst based in Covington, Georgia.

Summary of Position with General Responsibilities:

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.

Essential job Functions:

  • 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.

Basic Qualifications:

  • 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.

Additional Desirable Qualifications Skills and Knowledge:

LANGUAGE SKILLS

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.

MATHEMATICAL SKILLS

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.

REASONING ABILITY

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.

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