Associate Specialist Documentation

RXinsider LTD.; Minneapolis (MN); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical plan

Dental plan

Vision plan

HSA

Flexible Spending Accounts

Short Term Disability

Long Term Disability

Critical Illness Insurance

401(k)

Job summary

Abbott in Plymouth, MN is seeking an Associate Specialist Documentation for a 12-month, 100% onsite role. You will review and process change requests, maintain the Document Control System, and ensure all quality documents are accurate and compliant. Collaboration across sites and cross-functional teams is expected.

The position emphasizes strong organizational and problem-solving skills, with preferred Associates or Bachelor’s education and experience in regulated environments.

Qualifications

• Requires 2+ years in a regulated environment.
• Ability to clearly convey information.
• Influence and provide leadership on documentation requirements.
• Develop interpersonal relationships.
• Associates degree required or equivalent experience.

Responsibilities

• Review and process change requests for new and revised documents.
• Maintain and organize the Document Control System per quality/regulatory guidelines.
• Review, edit and approve/reject Quality System documents.
• Ensure document changes are justified and approved by required functions.
• Check documents for consistency with related specifications and labeling.
• Secure and control access to documentation per procedures.
• Coordinate document approvals with other sites.
• Participate on cross-functional project teams.
• Follow EHS rules and report incidents promptly.
• Implement and maintain effectiveness of the Quality System.
• Ensure product quality is linked to documentation accuracy.

Skills

Documentation control

Quality systems

Communication

Organizational skills

Problem-solving

Excel basics

Education

Associate degree

Bachelor's degree preferred

Tools

Excel

Document control system

Job description

Title

Associate Specialist Documentation

Location

Plymouth, MN

Duration

12 Months

Shifts

8AM TO 4:30PM

100% Onsite

Summary

• This position is responsible for reviewing and processing change requests for new documents and revisions to existing documents; responsible for processing, organizing and maintaining the Document Control System in accordance with applicable quality and regulatory guidelines.
• Review, edit and approve / reject Quality System documents. ensure that changes made to documents are appropriate, justified and approved by the required functional areas according to established procedures.
• Review documents for consistency with similar or related product specifications and labeling.
• Secure and control access of documentation as required by established procedures.
• Communicate and coordinate documentation approvals with other sites.
• Participate on cross-functional project teams.
• Other duties and responsibilities as assigned.
• Follow EHS rules and procedures for your department. report EHS incidents and / or unsafe acts and conditions promptly to supervision. forward any opportunities to improve the EHS program to supervision.
• Responsible for implementing and maintaining the effectiveness of the Quality System.
• Quality of the product is directly linked to the accuracy of the associated documentation.

Requirements

• Typically requires 2 or more years of relevant work experience or exposure within a regulated environment to sufficiently demonstrate the core job responsibilities of the position.
• Ability to clearly, concisely and accurately convey communications.
• Influence and provide leadership related to documentation requirements.
• Ability to form and develop interpersonal, professional relationships.
• An equivalent combination of education and work experience. Bachelors Degree preferred.
• Display socially and professionally appropriate behavior.
• Ability to work independently and in groups.
• Demonstrated initiative and problem-solving skills.
• Critical-thinking skills.
• Ability and aptitude to use various types of databases and other computer software.
• Ability to prioritize.
• Strong organizational skills and ability to manage projects.
• Ability and aptitude to provide solutions and contingency plans through the comprehensive review of alternatives.
• Not meeting requirements may result in delays and additional cost may be incurred.
• Must have great orgnaizational skills, know how to use basic Excel skills.
• This is an in-office position 100% of the time. Some background working in a professional office environment is helpful.
• Minimum of an Associates Degree (± 13 years) and may account for experience requirement.

Consultants Eligible Benefits Upon Waiting Period

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account (for High-Deductible Health Plans)
• Flexible Spending Accounts (Health, Limited Purpose, Dependent Care, Commuter Parking and Commuter Transit)
• Supplemental Life Insurance
• Short Term Disability (coverage varies by state)
• Long Term Disability
• Critical Illness, Hospital coverage, Accident Insurance
• MetLife Legal, MetLife ID Fraud, and MetLife Pet Insurance
• 401(k)

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, nutritional and branded generic medicines.

Working together, Abbott and Talent Solutions partner to deliver top talent for contingent roles at Abbott, building better and healthier lives. Abbott believes all employees are essential to creating life-changing breakthroughs, performing key duties to create life-changing breakthroughs.