Description:

Position Summary: Looking for an experienced Labeling Specialist to create and revise labeling components for In Vitro Diagnostic (IVD) products and related documentation regulated by the FDA and ISO 13485. This position requires a person who is detail-oriented, can manage multiple priorities, and has strong organizational skills. The Labeling Specialist must be accustomed to working within established timelines and have a high attention to detail. Major Responsibilities: Scope, redline and update labeling and documentation to support labeling changes. Prepares and routes documents through the eDMS system. Maintains open communication and customer support to various functional groups within the organization. Minimum Requirements/Qualifications: At least 2+ years of experience processing labeling changes in a regulated environment and/or 2+years in packaging engineering. Advanced organizational skills and ability to manage multiple priorities with the ability to work in deadline-oriented environment. Understanding of Good Documentation Practices (GDP) and Document Controls. Understanding of BOMs (Bill of Materials) and Specification documents. Must be able to write clear, understandable documentation. Education - High school diploma or Equivalent.

Skills:

Document control, Labelling, technical writing, technical documentation, Quality assurance, gdp, edms, redlining, bill of material, Regulatory, Medical device, iso 13485, documentation management

Top Skills Details:

Document control,Labelling,technical writing,technical documentation,Quality assurance,gdp,edms,redlining

Additional Skills Qualifications:

Minimum Requirements/Qualifications: At least 2+ years of experience processing labeling changes in a regulated environment and/or 2+years in packaging engineering. Advanced organizational skills and ability to manage multiple priorities with the ability to work in deadline-oriented environment. Understanding of Good Documentation Practices (GDP) and Document Controls. Understanding of BOMs (Bill of Materials) and Specification documents. Must be able to write clear, understandable documentation. Education - High school diploma or Equivalent.

Experience Level:

Entry Level

About Aston Carter:

Aston Carter provides world-class corporate talent solutions to thousands of clients across the globe. Specialized in accounting, finance, human resources, talent acquisition, procurement, supply chain and select administrative professions, we extend the capabilities of industry-leading companies. We draw on our deep recruiting expertise and expansive network to meet the evolving needs of our clients and talent community with agility and excellence. With offices across the U.S., Canada, Asia Pacific and Europe, Aston Carter serves many of the Fortune 500. We are proud to be a ClearlyRated Best of Staffing® double diamond winner for both client and talent service.

Diversity, Equity Inclusion

At Aston Carter, diversity and inclusion are a bridge towards the equity and success of our people. DEI are embedded into our culture through:

Hiring diverse talent

Maintaining an inclusive environment through persistent self-reflection

Building a culture of care, engagement, and recognition with clear outcomes

Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] (%[email protected]) for other accommodation options.