Acelity Careers

Document Control Analyst II

San Antonio, United States of America
Quality Assurance

Job Description

Purpose: This Position has advanced knowledge and understanding of Quality Document Control standards, provides oversight, and maintains the document control process and the electronic document control system.  This position also develops new processes using problem solving tools and performs project related tasks.  Additionally, the position manages/leads medium to large scale projects for improving, developing and implementing new processes within document control, label, and end-user system configuration management.  This position provides guidance to the Document Control staff in accordance with related document control projects and daily work in support of but not limited to the Quality, Regulatory, Design Engineering and Sustaining Engineering teams.

Principle Responsibilities

  • Sets standards for drawing and Quality Systems document review
  • Conducts reviews of drawings and documents to ensure standards are maintained using established policies and procedures
  • Provides oversight of status of the Change Order process for tracking of releases and changes
  • Ensures maintenance of the Change Order process including developing and reporting performance metrics
  •  Reviews metric data to anticipate issues and incorporates process improvements related to trends associated with data; also develops and implements solutions to issues that arise through research and evaluation of data
  • Provides end user system support and acts as liaison between Quality and the IT Administrator working in partnership to maintain the document control system
  • Provides support and guidance to hourly associates in drawing and document review; acts as SME on Quality Systems and Document Control topics
  • Supports Product Development/Manufacturing Engineering teams by providing SME input for the document control systems that support these departments, and may also schedule document control resources to support projects with minimal input from the Document Control Manager
  • Supports internal and external audits of the document management and change control processes
  • Develops effective training plans with milestones and conducts process training that includes but is not limited to Quality, Regulatory, Design Engineering and Sustaining Engineering
  • Ensures maintenance of product configuration to include updates to the MRP system including system configuration, and item setup
  • Manages/leads medium to large scope projects with an impact to multiple departments across the organization and performs project specific tasks, to include but not limited to:
    • Gather system requirements for midsize to large enhancements
    • Update and manage System workflow configuration
    • Develop and document test plans
    • Develop and implement department or corporate level training associated with the project

  • Provides Document Management specific research with regard to setups and process flow.
  • Participates in any and all reasonable work activities as deemed appropriate by management

Minimum Qualifications:

  • Bachelor’s degree in Business Administration, Technical Writing, Quality, Engineering Technology or related field
  • 3+ years of work experience to include Quality Assurance document control and Data System experience (e.g., navigating a data system, and providing work flow support using  out-of-the-box integrated system tools)

Preferred Qualifications:

  • 2+ years of technical writing experience
  • Software validation experience
  • Life Science or other regulated industry experience
  • Ability to build databases using Microsoft Access
  • Experience with Computer Aided Drawing (CAD) software
  • Electronic systems Document Control experience in the medical device industry

Other Desired Qualifications:

  • Proficient knowledge of quality system processes
  • Ability to work in a fast paced environment and react consistently and effectively to high volumes of work
  • Relevant software system experience to include projects such as those related to part 11 e-signature compliance and system validation releases and upgrades
  • Proficient computer skills with knowledge of relational databases, MS Office functions, and industry-standard document management solutions
  • Software validation experience
  • Project management skills such as influencing, creating support from senior management, and the ability to manage resources from multiple departments
  • Ability to read and understand technical drawings and information
  • Advanced knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices(GDP)
  • Advanced knowledge of electronic document systems
  • Ability to work in a team environment
  • Ability to prioritize workload and execute to meet deadlines
  • Ability to work with minimal to no supervision
  • Strong attention to detail and organizational skills
  • Strong verbal and written communication skills with experience in presenting various levels of quality system information to peers and senior level management
  • Process development and problem solving skills
  • Ability to travel 10-15%  by commercial air may be required for training and project support
The information listed above is not a comprehensive list of all duties/responsibilities performed. This job description is not an employment agreement or contract. Management has the exclusive right to alter this job description at any time without notice. Any physical and mental requirements described in this job description 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. EOE AA M/F/Vet/Disability: Acelity L.P. Inc. and its subsidiaries are an equal opportunity and affirmative action employer and give consideration for employment to qualified applicants without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, pregnancy, national origin, age, disability, veteran status, or genetic information or any other legally protected characteristic. If you'd like more information about your EEO rights as an applicant under the law, please click here: VEVRAA Federal Contractor