Sterilization/QAC Lab Analyst Job in Winston-Salem, North Carolina US
Sterilization/QAC Lab Analyst
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. PRIMARY FUNCTION: The QAC Lab Analyst is responsible for oversight of the sterilization program. This includes product evaluation process of new and modified products or packaging, documenting testing requirements such as bioburden, sub lethal sterility or residuals and develop required protocols/reports. In addition the QAC Lab Analyst will oversee the environmental monitoring program. JOB DUTIES: -Perform duties associated with our QAC Lab programs such as sterilization validation, microbiology, environmental monitoring, product bioburden, EO residuals and compressed air. -Perform validations of test equipment required for the environmental monitoring program. -Review new and modified products/packaging for sterilization. Oversee and maintain product evaluation processes for sterilization of new or modified products or packaging. Document any testing requirements such as bioburden, sub lethal sterility or residuals and develop required protocols/reports. -Perform duties associated with maintenance of laboratory equipment. -Oversee CMA certification reports, plus any additional environmental testing, for compliance to applicable standards. -Provide guidance and assistance to facilities personnel on technical questions and conformance issues. Investigate, document, and determine corrective action for sterilization deficiencies. -Develop and maintain procedures pertaining to Sterilization, Microbiology, and Environmental Monitoring. -Provide training to engineering personnel on the effects of product/packaging configurations on sterilization efficacy. -Provide training to facilities/manufacturing personnel on microbial contamination/disinfection requirements. -Maintain a working knowledge of all applicable sterilization standards. -Trend quarterly environmental data. -Perform other duties as necessary. POSITION QUALIFICATIONS: -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. ACCOUNTABILITY: -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. PHYSICAL AND ENVIRONMENTAL REQUIREMENTS -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).