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.
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