Kelly Services Documentation Specialist in Gurnee, Illinois
Contract position: 1-2 Months
Maintains a controlled documentation system, record retention, and information services function, including electronic records retention processes. Prepares and reviews required documentation such as good manufacturing practices (GMP), good laboratory practices (GLP), Device History Records (DHR’s), Certifications of Conformance (CoC’s), procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change authorizations in accordance with company policy and government regulations. Implements related documentation systems. May propose and/or implement change control processes. Coordinates the review and revision of procedures, specifications, and forms. Provides input on quality control procedures.
ESSENTIAL DUTIES AND RESPONSIBILITIES
With limited supervision, assures policies, procedures, inspection techniques and quality plans conform to established standards.
Performs complex analyses, packaging materials and/or finished products from manufacturing to ensure quality standards and compliance to customer and regulatory requirements.
Prepares and reviews DHR’s and CoC’s to support daily product release. Maintains the CoC database.
Assists in the regular review and assembly of systems release documents.
Creates new procedures, work instructions, quality plans, and other documents.
Makes changes to existing procedures, work instructions, quality plans and other documents using available systems tools.
Scans pictures, artwork, validation, etc. into the database.
Coordinates the revision, printing and distribution of controlled copies of quality plans, work instructions and procedures.
Assists in completing training and documentation requirements.
Assists in the creation of validation documents; edits as completed and tracks equipment that still needs to be validated.
Assists in control of SOPs, cGMP, ISO 13485, ISO9001, 21CFR820/210/211 and FDA/Regulatory requirements.
Support all company safety and quality programs and initiatives.
Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position.
EDUCATION AND EXPERIENCE
High school diploma required; Associate degree preferred
4+ years related experience and/or training
Or an equivalent combination of education, experience, and training.
Why Kelly ® ?
You’re looking to keep your career moving onward and upward, and we’re here to help you do just that. Our financial staffing experts will connect you with premier companies for opportunities where you can learn, grow, and thrive. Jobs that fit your skills and experience, and most importantly, fit right on your path of where you want to go in in your career. It all adds up.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.