Quality Assurance Associate - Document Control/Plant QA - CWs


Paris, KY
Employment Type: Contract (Shift: Days)

What were looking for: 

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

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. 
 

Details 
Worksite Location:  Paris, KY, 40361 
Worksite State:  | Kentucky 
Worksite Address Override:  | No 
Time Schedule:  | Default 5/40 
Start/End Date:  | 02/13/2025 to 08/31/2025 
Total Duration:  | 199 Days / 28.4 Weeks 
Hours per Day:  | 8.0 
Days per Week:  | 5 
Job Status:  | Full Time 

Nucleus Healthcare is a staffing and recruitment agency partnering with top-tier facilities and organizations to deliver quality candidates looking for meaningful employment. We have permanent placement and long-contract jobs nationwide in nursing, allied health, healthcare operations, and hospitality. Our vision of redefining the way healthcare does business is what fuels our mission to empower the people who power healthcare.
 

Additional Qualifications

  • QA experience