Plant QA

Education

• BA/BS in chemistry or science-related field preferred, or equivalent from two-year college or technical school.
• A minimum of two-year related experience and/or training; or equivalent combination of education and experience.

• A minimum of 2 years of experience in Quality, including cGMP and ISO standard.
• Experience with cGMP and MS Word, PowerPoint, and Excel.

• 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 with good social skills.
• Must be able to interface effectively with all levels of company employees.

• Issuance of controlled manufacturing and testing documents to Manufacturing and Quality Control as per the production schedule.
• Issuance of controlled labels used for labeling finished goods and other related samples.
• Monitor the equipment program, including calibration and preventative maintenance timelines, and complete quality assurance sign-off for equipment work orders.
• 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 a 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 the customer is met in a timely manner.
• Management of Label Program, including development of master labels, maintaining 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.

• Typically works in an office environment with adequate lighting and ventilation and a normal range of temperature and noise level.
• May also work in a 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 a 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.