Employment Type : Full-Time
At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.
POSITION SUMMARY
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.
Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.