Specialist II Change

About the Company

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.

About the Role

Lead and direct department employees to accomplish departmental goals, maintain workload balance, monitor incoming work levels to ensure timely processing of changes, and communicate priorities and changes. Provide monthly metrics to the Supervisor/Manager for inclusion in monthly reports. The Sr Coordinator will ensure the group completes effective change request administration, properly applies configuration control concepts, provides technical support to project teams, maintains controlled documentation and records, and ensures adherence to written documentation policies and procedures. Provide training and guidance to employees and assist in resolving issues.

Responsibilities

• Coordinate and control the processing of document and part changes, including delegation within Documentation Control and coordination of urgent changes.
• Monitor incoming change requests and ensure timely processing.
• Communicate business priorities to manage high-priority changes and meet business objectives.
• Act as the first point of contact for Documentation Specialists regarding questions or concerns.
• Provide training and coaching to Documentation Specialists.
• Assist in coordinating document control activities to meet departmental goals and project deadlines.
• Deliver Windchill training to users.
• Provide feedback (positive and corrective) to Document Control Specialists based on management or user communication.
• Coordinate implementation of change requests with all affected areas and facilities.
• Work with remote facilities or affected sites to assist in changes impacting multiple locations.
• Spend approximately 50% of time developing and leading Document Control Specialists and working on projects (may vary based on site size and workload).
• Compile monthly data and submit to Supervisor/Manager for inclusion in monthly reports.
• Maintain and update departmental procedures as required.
• Provide guidance and support to employees to understand documentation concepts and requirements.
• Participate in testing Windchill changes as requested.
• Keep departmental employees informed of procedural changes or updates.
• Support Divisional and Company initiatives in alignment with Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Requirements

• Equivalent High School Diploma / GED or a combination of education and work experience.
• Minimum 1–5 years of experience in an FDA or ISO-controlled industry.

Preferred Qualifications

• Additional training in Document Control and Configuration Management concepts.
• Knowledge of FDA, GMP, and ISO 13485.
• Ability to deliver training in a classroom setting or one-on-one.
• Experience directing or guiding departmental personnel.
• Solid computer and report-writing skills.
• Knowledge of ERP/PDM databases (e.g., SAP, Mfg-Pro, Windchill).
• 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.
• Strong verbal and written communication skills, with the ability to effectively communicate at multiple levels in the organization.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills, with attention to detail.

Benefits

• Career development with an international company.
• Free medical coverage in the Health Investment Plan (HIP) PPO medical plan (employees may qualify in the next calendar year).
• Excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, Freedom 2 Save student debt program, and FreeU education benefit for affordable bachelor’s degree paths.
• Recognition as a great place to work in dozens of countries worldwide, including being named one of Fortune’s most admired companies.
• Recognition as one of the best big companies to work for, as well as the best place to work for diversity, working mothers, female executives, and scientists.

Pay

The base pay for this position is $25.00 – $50.00 per hour. In specific locations, the pay range may vary from the range posted.