Abbott Quality Systems Documentation Specialist – Altavista, VA. in Altavista, Virginia
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Abbott Nutrition is a division of Abbott, the global, broad-based health care company. Every day, our global team of scientists is working hard to discover and develop nutritional and related health care products that advance the quality of life for people of all ages.
Health care professionals and their patients trust us to provide cutting-edge nutrition products that meet changing nutrition needs. And we deliver on their expectations—providing a vast array of nutritional and therapeutic products that help babies and children grow, work to keep bodies strong, and support the unique needs of patients with chronic illnesses
The Quality Documents Specialist’s primary responsibility is specialized editing and programming in the advanced electronic systems being used to replace paper systems, for example POMSnet (electronic auditing and batch records), and Lab Information Management System (LIMS). Additional duties are updating and revising the merged Work Orders (the primary set of instructions for the production of each product type); responsible for having the correct batch calculation program entered into the QA Work Order System; responsible for preparing and maintaining all quality-related documents, manuals, protocols, policies, procedures, and methods which define and document the quality control system; assuring that the document system is properly distributed and controlled; maintaining an effective system for making authorized system changes to individual documents; and coordinating and implementation and/or expiration of quality document procedures, requirements, and specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES: The Quality Documents Specialists is responsible for programming the electronic batch record and auditing system (POMS) which replaces work order instructions and enforces procedures in a specific process flow using linear graphic control syntax and transition logic. The position is also responsible for test mapping products into LIMS to prepare the electronic work order used in the Analytical Lab and to assure the correct test, at the right stage of production, and have the correct specifications for the production for each fluid code product. Update, track, issue, and implement all Master Work Orders and all other quality-related documents (including Quality Assurance (QA) controlled forms, Label Edition changes, procedures, policies, Deviations, lab methods, acceptance programs, etc.) in accordance with the Quality Assurance Document Policy. Assure that Work Orders are issued with correct specifications, critical factors, formulation, and packaging materials. Also, responsible for the printing, verification, and distribution to the various manufacturing departments of batch specific plant production Work Orders. They are responsible for ensuring that Work Orders and all other documentation are up to date and correct thus preventing the possibility of an FDA observation, Corporate Compliance Audit observation, SQF Audit observation, product recall, or the possibility of serious errors that could adversely affect the nutritional efficacy, physical or microbiological stability of the manufactured product. Other duties may be assigned.
Bachelor's degree (B.A.) from a four-year college or university is preferred; or three to five years of related experience and/or training; or equivalent combination of education and experience. Extensive computer experience is required, including key boarding, word processing, computer programming (Visual Basic, C#), and flow charting. When a Senior Documents Coordinator takes classes in programming, takes on the added responsibilities and becomes proficient at test mapping LIMS and coding transition logic in POMS then they will be promoted to a Quality Systems Specialist.
LANGUAGE SKILLS: Program Logic, ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs.
REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, flow chart, computer transitional logic, or schedule form.
PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to remain seated at a computer work station. The employee frequently is required to use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee is also regularly required to stand and walk throughout the plant as a means of document distribution to required plant locations. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.
ANSC Nutrition Supply Chain
United States > Altavista : Building 1
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis
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
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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