QAC Lab Analyst
Cook Medical - Winston-Salem, NC

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Since 1963, Cook Group companies have been among the leaders in developing healthcare devices that have improved lives around the world. COOK remains at the forefront of medical research and worldwide sales of products for endovascular therapy, critical care medicine, general surgery, diagnostic and interventional procedures, bioengineered tissue replacement and regeneration, gastroenterology and endoscopy procedures, urology, and obstetrics and gynecology. COOK is a global company with a global focus - and a global future.

The Endoscopy Strategic Business Unit was established to provide innovative products for gastrointestinal endoscopy. By working closely with prominent gastroenterologists, Cook Endoscopy has become a worldwide leader in the design, development and manufacture of devices used in gastrointestinal endoscopy, bronchoscopy, and surgery, in the treatment of esophageal, stomach, pancreatic, liver and colon disorders. Key product lines include but are not limited to sphincterotomes, wire guides, biliary stents, forceps, needles, cytology brushes, multi-band ligators, Percutaneous Endoscopic Gastrostomy systems (PEGs) and polypectomy snares.

The primary purpose of this position is to maintain the environmental monitoring which includes environmental monitoring and microbial testing, product bioburden testing and to maintain the environmental program. This position will also assist with the product sterilization program.

  • Perform duties associated with our QAC Lab environmental monitoring program such as particulate, viable surface air, compressed air, fingertip, and product bioburden testing.
  • Provide training to facilities/manufacturing personnel on microbial contamination/disinfection requirements.
  • Perform validations of test equipment required for the environmental monitoring program.
  • Develop and maintain procedures pertaining to Microbiology and Environmental monitoring.
--Provide guidance and assistance to facilities/engineering personnel on technical questions and conformance issues.

  • Perform duties associated with maintenance of laboratory equipment.
  • Oversee CMA certification reports, plus any additional environmental testing, for compliance to applicable standards.
  • Assist with the sterilization program such as sterilization validation, product/packaging evaluations for various sterilization methods, EO residuals, and the development and maintenance of procedures pertaining to Sterilization.
  • Assist with documenting any testing requirements such as bioburden, sub lethal sterility or residuals and develop required protocols/reports.
  • Assist with investigating, documenting, and determining correct action for sterilization deficiencies.
  • Assist with providing training to engineering personnel on the effects of product/packaging configurations on sterilization efficacy.
  • Maintain a working knowledge of all applicable sterilization standards.
  • Trend quarterly environmental data.
  • Perform other duties as necessary.
  • 4 year degree with background in Chemistry, Biology or Sterilization or equivalent experience in management and application of lab processes.
  • Good computer entry/retrieval skills, including a working knowledge of Word, Excel, and Access software.
  • Working knowledge of microbiology, including environmental sampling and testing requirements. Knowledge of aseptic technique.
  • Good written and verbal communication skills. Experience in technical writing including procedures, protocols and reports.
  • Proven problem-solving skills.
  • Good organizational skills.
  • Detail-oriented.
  • Reports directly to the Internal Audit/Environmental Manager. Works independently, referring problems or questions to the Internal Audit/Environmental Manager.
  • Confidential access to new or modified product designs and the development process.
  • Confidential access to product lines.
  • Responsible for compliance with the Company’s Sexual Harassment policy.
  • Responsible for compliance with the Company’s Quality Policy Manual.
  • Responsible for compliance with the Company’s Harassment policy.
  • Responsible for compliance with the Company’s Workplace Violence policy.

  • Must be able to perform essential functions of job, with or without reasonable accommodations.
  • Work is performed in a normal office type working environment with the majority of the day spent sitting and moving around various departments.
  • Lab work requires protective glasses, gloves and lab coat when working with viable microorganisms.
  • Ability to travel 5% of the time (if applicable).

About this company
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Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...