What are the responsibilities and job description for the CW - Quality Assurance Associate - Document Control/Plant QA position at TALENT Software Services?
Quality Assurance Associate
7001 Martin Luther King Jr. Blvd., Paris, KY, 40361
6 Months Contract
Onsite Interview is Required.
Join our team as a Quality Assurance Associate in the heart of Paris, where you will play a crucial role in maintaining the highest standards of quality and safety in our operations. This position offers a unique opportunity to work in a dynamic environment, contributing to the success of our plant's quality assurance and document control initiatives.
What We're Looking For
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise levels. May also work in a warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on products.
Work assignments are diversified, and examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on a routine basis. Minimal physical effort is required, as work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.
7001 Martin Luther King Jr. Blvd., Paris, KY, 40361
6 Months Contract
Onsite Interview is Required.
Join our team as a Quality Assurance Associate in the heart of Paris, where you will play a crucial role in maintaining the highest standards of quality and safety in our operations. This position offers a unique opportunity to work in a dynamic environment, contributing to the success of our plant's quality assurance and document control initiatives.
What We're Looking For
- Education: BA/BS in chemistry or a science-related field preferred, or equivalent from a two-year college or technical school. A minimum of two years of related experience and/or training; or an equivalent combination of education and experience.
- Experience: A minimum of 2 years of experience in Quality, including cGMP and ISO standards. Proficiency in MS Word, PowerPoint, and Excel.
- Knowledge of Quality Assurance/Quality Control/Operations in a regulated environment.
- Familiarity with lab equipment operation and set-up.
- Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
- Strong report writing and procedural documentation skills.
- Excellent presentation skills and the ability to respond to questions from groups of managers, clients, customers, and the public.
- A great teammate with good social skills.
- Effective interfacing with all levels of company employees.
- Manage the issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule.
- Oversee the issuance of controlled labels for labeling finished goods and related samples.
- Monitor the equipment program, including calibration and preventative maintenance timelines, and complete quality assurance sign-off for equipment work orders.
- Coordinate the release of raw materials after reviewing and approving supporting documentation, including supplier and quality control testing records.
- Conduct reconciliation, filing, and archiving of all quality-controlled records. Store completed documents in the appropriate data files and coordinate off-site document storage with a third party as necessary.
- Provide pre-run line clearance to manufacturing when needed.
- Consult with document originators to resolve discrepancies.
- Work closely with internal departments to ensure timely commitment to customer needs.
- Manage the Label Program, including the development of master labels, maintaining controlled label stock, setting inventory safety stocks, printer supplies, and coordinating reorders.
- Provide batch record review support as required.
- Write and revise SOPs as part of process improvement initiatives or to support the department's needs.
- Coordinate document control activities and delegate tasks with other quality coordinators to drive workload completion under the direction of quality management.
- Actively participate in and drive the quality and safety culture of the site.
- Perform other duties as assigned.
Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise levels. May also work in a warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on products.
Work assignments are diversified, and examples of past precedent are used to resolve work problems. New alternatives may be developed to resolve problems. A frequent volume of work and deadlines impose strain on a routine basis. Minimal physical effort is required, as work is mostly sedentary but does require walking, standing, bending, reaching, lifting, or carrying objects that typically weigh less than 10 lbs.
