Plastikon Healthcare Tampa, KS 67483, USA
Nov 12, 2019
At Plastikon Healthcare, we’re looking for Team Members who want to be part of producing the highest quality medicines and medical devices. Consider applying here, if you want to: Work in an entrepreneurial and dynamic environment where you can make an impact. Have the opportunity to build a long-lasting and satisfying career. Feel GREAT about making others feel better We offer competitive compensation and benefits packages for our Team Members. QC Microbiologist I-III DUTIES & RESPONSIBILITIES: The QC Microbiologist is responsible for developing, and conducting laboratory testing to support the cGMP manufacturing operations. The QC Microbiologist performs tests in chemistry and microbiology disciplines. Testing includes sampling of raw materials, environmental sampling of classified areas, sterility and bioburden testing, water testing, microbial identification, particulate monitoring, water testing, and HPLC assays. This position requires attention to detail, requiring a proactive individual who is capable of assisting in new assay development and product transfers. The QC Microbiologist will be responsible for generating and revision laboratory procedures, performing audits, and analyzes data for compliance. The QC Microbiologist reports directly to the QC Manager. . Job Roles required of the position: · Microbiologist, Lab Tech, QC Line Testing, and Clean/Sanitization of Lab: Performs testing and performs various activities in support of these job roles, develops methods, and works with lab team to ensure compliance to procedures. Assumes accountability for work performed. Assists in peer review of reports and documents for compliance to requirements. Reviews and approves data for compliance. Generates reports in support of the Quality System, as required. · Validation: Supports validation activities in manufacturing. Generates and executes protocols for product transfer and method validation. · Purchasing: Uses the purchasing system to procure laboratory and validation supplies. · DCR System: Actively uses the DCR System to generate or revise document, as needed. · CIMP System: Provides support for continuous improvement and Kaizen events and projects. · NCR System: Supports the nonconformance system through reporting of Non-conformances and supporting Quality in investigation activities. Provides reports and communication based on investigation findings · Other duties as assigned. EDUCATION / EXPERIENCE: Minimum Requirements: BS in science major or extensive equivalent experience, 5 years in microbiology with experience in a pharmaceutical or medical device facility. Experience in ISO standard execution, cGMP and Quality Systems. Skills/Qualifications: Aseptic technique, wet-chemistry, method development, calibration and lab equipment maintenance, variety of microbiological assays including sterility testing, microbial counts, microbial isolation and identification, environmental monitoring, and water testing. Skills in analytical instrumentation preferred. LANGUAGE SKILLS: Required reading, writing and speaking fluently in English and preparing reports. PHYSICAL DEMANDS: While performing the responsibilities of the job, the employee is required to talk and hear. The employee is required to sit, stand, walk, reach with arms and hands, lift objects, and use their hands and fingers, to handle or feel. The employee is occasionally required to climb or balance, stoop, and kneel, crouch or crawl. Vision abilities required by this job include close vision. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. WORK ENVIRONMENT: While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts and vehicles. The employee is exposed to laboratory chemical reagents and microbial cultures. The noise level in the work environment is usually quiet to moderate; some activities require personal protective equipment, which is provided. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.