Aseptic Filling Technician- 2nd Shift

ROLE SUMMARYWorks in a clean room environment which requires gowning qualification and adherence to goodaseptic techniques to produce aseptically filled injectable drug products. The position requirescGMP understanding and involves operating of the filling machines and aseptically assemblingcomponents used on some of the RESPONSIBILITIES Follows aseptic behavioral requirements. Follows cGMP requirements Operate component assembly machines and filling machines. Unload sterilizers properly handle components and machine parts. Perform proper accountability & documentation batch records logbooks and other GMPdocuments) Works in a clean room environment. Perform cleaning and disinfection / sanitization of stationary equipment room surfaces in allcGMP room areas to ensure compliance with all sanitization procedures to maintain a sterileenvironment. Perform appropriate department housekeeping duties per SOPs. Other duties as assigned (e.g. drug filtration personnel plating daily inventory clean roomparts checks etc.) Participate in process improvements activities. Will demonstrate behaviors aligned to the companys PRECISE QUALIFICATIONS High school diploma or general education degree (GED) or associates degree. Must be able to read and comprehend instructionscorrespondence and technical documents. Must demonstrate the ability to add subtract multiply and divide in all units of measureusing whole numbers common fractions and decimals. Ability to perform calculations for percent accountabilities and reconciliation of numericalvalues. Proficiency in operating computerized systems and software. Must demonstrate the ability to apply common sense understanding to carry out instructionsfurnished in written oral or diagram form. Must follow and review detailed documentation for accuracy and QUALIFICATIONSTo perform this job successfully an individual must be able to perform each essential dutysatisfactorily. The requirements listed below are representative of the knowledge skill and/orability required. Reasonable accommodation may be made to enable individuals with disabilities toperform the essential functions. Position requires bending stooping squatting pull/push and reaching above the shoulderlevel. Ability to read and comprehend simple instructions correspondence and memos. Ability to write correspondence. Ability to effectively present information in one-on-one and small group situations to otheremployees of the organization. Must be able to pass Sterile gown and media fill qualification. Position may require use of a QUALIFICATIONSThe physical demands described herein are representative of those that must be met by an employeeto successfully perform the essential functions of this job.1. The employee is regularly required to use hands to finger handle or feel objects tools orcontrols.2. The employee is regularly required to stand and walk; climb or balance; and stoop kneelcrouch or crawl.3. The employee must occasionally lift and/or move up to 40 pounds.4. Specific vision abilities required by this job include close vision distance vision colorvision peripheral vision depth perception and the ability to adjust and focus.5. Cannot be claustrophobic.6. Must achieve a score of 9 or above for near vision (14) with both eyes using a Titmus II visiontester.7. Position requires bending stooping squatting pull/push and reaching above the shoulder level.8. The employee must wear all required safety equipment and perform assigned work in a safe manner.9. Employee must use proper lifting techniques and beconscious of hazards around him/her.