AVANTOR: CW - Quality Assurance Associate - Document Control/Plant QA

Who you are:

• Knowledge of Quality Assurance/Quality control/Operations in a regulated environment
• Familiar with lab equipment operation and set-up.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports and procedures.
• Ability to successfully present information and respond to questions from groups of managers, clients, customers, and the public.
• Great Teammate and good social skills
• Must be able to interface effectively with all levels of the company employees

How you will thrive and create an impact

• Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule.
• Issuance of controlled labels used for labelling finished goods and other related samples.
• Monitor the equipment program including calibration and preventative maintenance timelines and complete quality assurance sign-off for equipment workorders.
• Issuance and reconciliation of equipment and room logbooks.
• Coordinate the release of raw materials after completion of review and approval of 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 third party as necessary.
• May provide pre-run line clearance to manufacturing.
• Consult with document originators to resolve discrepancies.
• Work closely with internal departments to assure commitment to customer is met in a timely manner.
• Management of Label Program. Includes development of master labels, maintain controlled label stock, setting inventory safety stocks, printer supplies, and coordinating reorders.
• May provide batch record review support.
• Writing and revising SOPs as part of process improvement initiatives or as needed to support the department.
• Coordination of document control activities and delegating with other quality coordinators to drive workload completion at the direction of quality management.
• Actively participate and drive the quality and safety culture of the site.
• Performs other duties as assigned

Environment

• Typically works in an office environment with adequate lighting and ventilation and a normal range oftemperature and noise level. May also work in warehouse setting with appropriate protective wear if performing pre-fill, in-process, and final inspections on product.
• Work assignments are diversified. 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 routine basis.
• Minimal physical effort is required. Work is mostly sedentary but does require walking, standing, bending, reaching, lifting or carrying objects that typically weigh less than 10 lbs.