Coordinator II Document Control

Abbott Laboratories; California, Northern (MO, KY); Hybrid; USD 28,000 - 56,000; Full time

Benefits offered by this job

HIP PPO health coverage

Retirement plan with employer contrib.

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Sylmar, United States, seeks a Coordinator II, Document Control to manage change requests, maintain controlled documents, and enforce documentation policies. The role supports project teams and ensures accurate Bill of Materials and device history through meticulous control of part numbers and revisions.

You will work with remote facilities as needed, maintaining logs and providing technical support to Engineering projects to meet deadlines and ensure compliance with FDA regulations

Qualifications

• Minimum 4 years related work experience.
• Solid computer and report-writing skills.
• Ability to work in a highly matrixed and geographically diverse environment.
• Excellent written and verbal communication across levels.

Responsibilities

• Assure effective Change Order Administration.
• Coordinate and control documentation change requests and procedures.
• Maintain logs and records related to documentation control.
• Provide technical support to Engineering projects and ensure timely implementation of changes.

Skills

Change control

Documentation

Data entry

Communication

Education

High School Diploma / GED

Tools

Microsoft Office

Job description

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 115,000 colleagues serve people in more than 160 countries.

Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

Main Purpose

The Coordinator II, Document Control position is responsible for effective change request administration, properly applied configuration control concepts, providing technical support to project teams as required, maintenance of controlled documentation and records, maintenance of documentation databases and enforcing adherence to written documentation policies and procedures.

Main Responsibilities

• Assure Effective Change Order Administration.
• Ensure that all change requests comply with procedure requirements.
• Coordinate and control the processing of all documentation change requests, procedures, and appropriate documentation.
• Coordinate implementation of change requests with all affected areas/facilities.
• Prioritize and schedule completion of approved change orders
• Work with remote facilities as necessary to assist in changes that affect multiple locations.
• Maintain appropriate logs and records.
• Provide assistance to change requestors in updating documents, creating or updating Bills of Materials and submitting change requests etc.
• Maintain accurate configuration control: Control part numbers and revision level assignments.
• Maintain product configurations by ensuring accuracy of Bills of Materials.
• Control Device Master Records.
• Maintain item master accuracy by updating additions, deletions, and other changes as required.
• Assure effective documentation control administration: Monitor and prioritize routine documentation activities and requests to ensure customer expectations are met.
• Distribute notifications and updated documents to applicable areas, as required.
• Proofread documents for accuracy and adherence to policies, as necessary.
• Provide technical support to Engineering projects: Support Engineering projects to ensure accurate product configuration and documentation of new products.
• Support project teams to ensure change requests are implemented to meet deadlines.
• Support Custom Device Requests to ensure accurate documentation, as necessary.
• Miscellaneous: Create change orders for personnel as requested.
• Provide support to archiving activities.
• Support Customer requests such as; retrieval of old history including down rev. documents and device history, provide copies of procedures and/or procedure books as necessary, update distribution lists etc.
• Evaluate activities and identify areas of improvement and carry out improvement activities.
• 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.

Qualifications

Education

High School Diploma / GED

Experience

Experience Details Minimum 4 years 4-5 years related worked experience.

• 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.

The base pay for this position is $20.25 – $40.55/hour In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality

DIVISION: CRM Cardiac Rhythm Management

LOCATION: United States > Sylmar : 15900 Valley View Court

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.

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