Warehouse Quality and Documentation Senior Specialist

Abbott; Madison (WI); On-site; USD 78,000 - 156,000; Full time

Job summary

Abbott is seeking a Sr. Warehouse Quality & Document Specialist in Madison, WI to oversee quality compliance for international and domestic movements, warehouse operations, and materials management. This role ensures audit readiness under the enterprise QMS and drives quality improvements across the network.

You will manage SOPs, WI’s, forms, and job aids, serve as SME for quality projects and audits, and coordinate reporting and metrics. Travel is up to 20% to support multi-site operations.

Qualifications

• Bachelor’s degree or equivalent with related experience (see requirements).
• 5+ years of proven experience in operations quality control/assurance.
• 4+ years of experience with warehouse management/ERP systems.
• 3+ years of experience with Quality Management Systems and compliance.
• Experience in a GMP/CAP/ISO13485 environment preferred.
• Proficiency with MS Office, especially MS Excel.
• Results-driven work ethic and ability to work independently.
• Ability to perform essential duties with or without accommodation.

Responsibilities

• Oversee Quality Documentation, coordinate activities across departments, and monitor change controls within and initiated for the Logistics & Distribution group.
• Manage the creation and auditing of all warehouse SOPs, WIs, forms, and job aids.
• Act as SME to represent Warehouse in Quality projects, audits, and other Quality events.
• Act as Warehouse Quality SME on Inspection Plans (IPs); measure IPs, evaluate performance, and identify improvements.
• Remain current on Warehouse policies and procedures through training and audits for receiving, inspection, and verification of incoming materials.
• Develop and maintain metrics to drive process improvements and provide leadership visibility.
• Collaborate with Corporate and Clinical Quality to ensure compliance across processes.
• Support ERP activities and expansion related to Warehouse quality compliance.
• Standardize submission of quality documentation for all warehouse/logistics activities.
• Support internal quality assessments and corrective actions with location teams.
• Use metrics to inform adjustments and optimize processes enterprise-wide.
• Support annual risk assessments and development of improvement plans.
• Maintain systems and technology to support quality programs and warehouse safety.
• Demonstrate teamwork and cross-functional collaboration.

Skills

Quality management systems

GMP/CAP/ISO13485 experience

Analytical skills

Results-driven

Education

Bachelor’s degree in Logistics/Supply Chain/Industrial Engineering

GED with 4 years of experience

Tools

MS Excel

ERP systems

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.

JOB DESCRIPTION:

The Opportunity

The Sr. Warehouse Quality & Document Specialist will lead, support, and direct efforts as it relates to quality compliance and controls across international and domestic product movements, warehouse operations and materials management. They will be responsible for supporting the development, implementation, and maintenance of an all-encompassing quality compliance program that aligns with our enterprise QMS and ensures audit readiness at all Abott’s locations. They will support the optimization of Quality Operations across all warehouses, enterprise-wide.

What You’ll Work On

Include, but are not limited to, the following:

• Oversee Quality Documentation, coordinate activities across departments, and monitor change controls within and initiated for the Logistics & Distribution group.
• Manage the creation and subsequent auditing of all warehouse SOP’s, WI’s, forms, and job aides.
• Provide primary support and act as the Subject Matter Expert (SME) to represent the Warehouse in Quality project, audits, and other Quality events.
• Act as Warehouse Quality SME on Inspection Plans (IPs); measuring IPs operational impact, evaluating performance, and finding ways to improve the process.
• Remain current on all Warehouse policies and procedures through training and audits of policies and processes for receiving, inspection, and verification of incoming materials.
• Support the development and maintenance of metrics to drive process improvements and ensure visibility to leadership and team.
• Partner closely with Corporate and Clinical Quality as it relates to Warehouse and Distribution activities, ensuring all processes and operations are compliant, with Quality support and contribution.
• Support ERP activities and expansion, evaluating and leading efforts around Warehouse quality compliance.
• Standardize the submission of quality documentation related to all warehouse/logistics activities, enterprise-wide.
• Support internal quality assessments using key internal and third-party tools to determine strengths and weaknesses and implement corrective actions with location operations teams.
• Use historic, current, and predictive metrics to inform adjustments/decisions in effort to optimize processes across warehouses enterprise-wide.
• Support the implementation of annual risk assessments to determine level of compliance, and the development of scorecards and improvement plans.
• Maintain systems and technology to improve quality programs support warehouse safety and adhere to any changing regulatory needs.
• Proven ability to work effectively in team situations, cross-functionally as well as independently.
• Assist with Warehouse Operations process and improvement projects.
• Excellent oral, written communication, and interpersonal skills.
• Strong documentation skills and attention-to-detail necessary in a GMP and CAP environment.
• Strong analytical and problem-solving skills.
• Ability to adapt to a quickly changing work environment with rapidly changing needs and requests.
• Uphold company mission and values through accountability, innovation, integrity, quality, and teamwork.
• Support and comply with the company’s Quality Management System policies and procedures.
• Ability to work nights and/or weekends.
• Ability and means to travel between local Abbott’s locations.
• Ability to travel 20% of working time away from work location, may include overnight/weekend travel.

Required Qualifications

• Bachelor’s degree in Logistics, Supply Chain, Industrial Engineering, or a field outlined in the essential duties; or High School Diploma or General Education Degree (GED) and 4 years of relevant experience as outlined in the essential duties in lieu of Bachelor’s Degree.
• 5+ years of proven experience in operations quality control / assurance.li>
• 4+ years of experience with warehouse management/ERP systems.
• 3+ years of experience with Quality Management Systems Experience with compliance and quality standards.
• Experience in a laboratory environment, preferably in a GMP, CAP and/or ISO13485 environment.
• Proficiency with MS Office with strong MS Excel skills.
• Results driven work ethic.
• Demonstrated ability to perform the essential duties of the position with or without accommodation.

Preferred Qualifications

• Proficient in Agile, Oracle, SAP, or other Quality Management System and ERP applications.

The base pay for this position is

$78,000.00 – $156,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Supply Chain

DIVISION:

ONCO Cancer Diagnostics

LOCATION:

United States > Madison : 650 Forward Dr

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 20 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

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