Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
The Document Control Coordinator Specialist leads and directs department employees to accomplish departmental goals, maintains workload balance, monitors incoming work levels to ensure timely processing of changes, communicates priorities and changes, and provides monthly metrics to the Supervisor/Manager for inclusion in monthly reports.
- Ensures the group completes effective change request administration, properly applies configuration control concepts, and provides technical support to project teams as required.
- Maintains controlled documentation and records, maintains documentation databases and ensures adherence to written documentation policies and procedures.
- Provides training and guidance to employees, identifies and assists with resolving issues.
- Coordinates and controls the processing of document and part changes, including delegation within Documentation Control and coordination and assignment of urgent changes.
- Monitors incoming change requests and ensures that changes are picked up and processed in a timely manner.
- Communicates business priorities to ensure high priority changes are managed to meet business objectives.
- Acts as first point of contact for Documentation Specialists when questions/concerns arise.
- Provides training and coaching to Documentation Specialists.
- Assists in the coordination of the document control activities to meet departmental goals and project deadlines.
- Delivers Windchill training to users.
- Provides information and feedback, both positive and corrective, to Document Control Specialists based on communication from management or users.
- Coordinates implementation of change requests with all affected areas/facilities.
- Works with remote facilities/affected sites as necessary to assist in changes that affect multiple locations.
- Compiles monthly data and submit to Supervisor/Manager for inclusion in monthly report.
- Maintains departmental procedures and updates as required.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned
- High School degree or equivalent required.
- 2-5 years experience
- Additional training of Document Control and Configuration Mgmt concepts.
- Knowledge of FDA, GMP, and ISO 13485.
- Ability to deliver training in a classroom setting or one-on-one.
- Be able to direct or guide departmental personnel.
- Solid computer skills and report writing skills.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to maintain regular and predictable attendance
JOB FAMILY:Operations Quality
DIVISION:MD Medical Devices
LOCATION:United States > Pleasanton : 6035 Stoneridge Dr
TRAVEL:Yes, 5 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf