Job brief
This position requires the following for employment at Stallergenes Greer and includes but not limited to :
Job Task(s)
- Partially responsible for training in all areas of the department as needed
- Assist Crew Leader with tasks as needed : Coordinates scheduling of routine activities and assigns tasks to personnel. Coordinates activities of personnel to effectively meet production timelines. Checks inventory and orders supplies as necessary based on schedule.
- Assists with investigations of deviations. Ensures batch documentation is being completed according to appropriate GMP standards.
- Has technical skills to troubleshoot problems as they arise and to identify potential issues. Communicates issues requiring maintenance to appropriate personnel.
- Communicates production status in a timely manner.
- Effectively communicates schedule or process changes to affected personnel in a timely manner.
Equipment Wash / Responsibilities
Operates lab equipment.Washes, rinses, dries, inspects, and wraps glassware, vials, and equipment.Sterilizes or dehydrogenates vials, glassware, and equipment.Maintains inventory of materials needed to complete production.Accurately documents work performed on documentation records or appropriate forms.Crimp Room Responsibilities
Pull seals per Work Order for days productionBreakdown of equipmentClean room and equipment pre- and post-productionReturn any unused seals to warehouseResponsible for pulling Sterility and LAL samples for QAMix Room Responsibilities (Upon Completion of additional training and qualification)
Use balances to measure bulk chemicals by specifications on Batch RecordFollow Documentation and SOPs to produce Sterile Diluents for productionTransfer Sterile Diluent to Clean RoomPerform Integrity testing on filters post-productionFollow Documentation and SOPs to clean equipment pre- and post-productionSterile Room Responsibilities (Upon Completion of additional training and qualification)
All Sterile Technicians will be required to participate in and have a passing Media Fill Trial before allowed to produceUnload DHO and Autoclave dailyOperate Equipment according to SOPPerform volume checks as requiredProduce Diluent / Sterile Empty Vials and operate Stoppering MechanismBreak down and sanitize equipment and change parts post-productionSetup fill line for next day’s productionRequirements
Work Experience Requirements
5 year’s work experience in manufacturing2 years experiences training / leading othersExperience working with a medium / high speed fill lineIsolator / Rabs experience a plusAbility to write / modify GMP documents & write / review deviationsEducation Requirements
This position requires the following minimum education :
High School Diploma or equivalent.Associate’s degree / Certification in Biology / Pharma related discipline preferredThe physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires Type 4 Garb qualification (Sterile Containment Suit, Sterile Hood, Sterile Face Mask, Sterile Gloves, Sterile Boots, and Sterile Goggles).Must be able to perform Personnel Monitoring for every entrance into Clean Room.While performing the duties of this job, the employee is frequently required to sit and talk or hear.The employee is occasionally required to use hands to finger, handle, or feel.Specific vision abilities required by this job include close vision and ability to adjust focus.Computer Skill(s)
To perform this job successfully, an individual should have knowledge of Internet software; Spreadsheet software and Word Processing software.
