Manufacturing Technician-IV

Integrated Resources, Inc

Carlsbad, California

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JOB DETAILS

JOB TYPE

Full-time

SKILLS

Biology, Biotech and Pharmaceutical, Change Requests/Orders, Clinical Research, Code of Federal Regulations, Corrective Action, Current Good Manufacturing Practice (cGMP), Desktop PC, Documentation, Emergency Response, Equipment Validation, Establish Priorities, Facilities Management, First Aid, GMP (Good Manufacturing Practices), Information Technology & Information Systems, Internal Audit, Leadership, Maintain Compliance, Manufacturing, Manufacturing Management, Manufacturing Operations, Operations Processes, Purchasing/Procurement, Rehabilitation Nursing, Staff Training, Standard Operating Procedures (SOP), Startup, Time Management, Writing Skills

LOCATION

Carlsbad, California

POSTED

1 day ago

Manufacturing Technician-IVIntegrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.Job DescriptionTitle: Technician, Manufacturing 4Duration: 12 MonthsLocation: Carlsbad, CAWork hours: In general, hours are 8:00 am - 5:00 PM, the employee must be able to work off-shifts, weekends, and additional hours as required.Essential Job FunctionsTroubleshooting equipment and process failuresRecognize common equipment failures and process anomaliesAssist in Deviation Investigations, Corrective Action, Preventative Action, and Document Training.Author Document Change Requests for Batch Production Records, Standard Operation Procedures, Item Specifications, and Qualifications.LeadershipReinforce cGMP documentation guidelinesEmphasize importance of quality cGMP compliant documentation to coworkersProvide on-the-job training, emphasizing cGMP complianceProvide a positive reinforcing, open learning atmosphereTailor training style to meet individual needsSet a good example in observance of cGMP and QualityFollow up on instructions/suggestions to ensure complianceDemonstrate leadership by example and participationCompliance with safety guidelinesUse safety eyewear while inside a manufacturing areaKnow appropriate emergency response proceduresKnow locations of first aid kits, safety showers, spill kitsKnow evacuation route and assembly area to be used in case of fire or earthquakeKnow the location of MSDS binders and understand how the guidelines pertain to operationsFollow good chemical safety practicesComply with all cGMP Documentation and proceduresRecord information accuratelyMake corrections in a timely mannerCheck all necessary calculationsReview pre-recorded data for accuracy and completionEnsure all entries are neat and legibleUnderstand operator and verifier responsibilitiesReview labels and equipment calibrations prior to usePerform preliminary review of completed documentationKeep logbooks updated and accurateComply with cGMP Practices and RegulationsGenerate clear and concise labels for all in-process equipment and materialsUnderstand, observe, and practice proper gowningUnderstand flow of materials and personnel in the manufacturing areasMaintain clean and well-stocked labsTechnology transferAssist in the introduction of manufacturing schemes into the GMP manufacturing facilityAssist with the purchase of equipment required for new processesLead the startup and validation of new equipment with the assistance of the Validation groupAuthor the Standard Operation Procedures required to incorporate new production equipment into the manufacturing facility.Provide all the necessary training required to incorporate new production equipment into the manufacturing facility.Supervise, and perform as needed, the creation and revision of production documents in order to maintain cGMP compliance and efficiencyDemonstrate consistent initiative in generating documents and in providing revisions for all documentsSupervise, and perform as needed, employee trainingEnsure that training records are reviewed and regularly updatedReinforce cGMP documentation guidelinesProvide instruction and guidance to coworkers to prevent errorsOversee and maintain the departmental training programImplement innovative training programsCommunicate with members of the manufacturing group, and with other departments, as needed to optimize the production scheduleProvide frequent detailed operations updates to the appropriate members of the Manufacturing groupHold operations meetings regularly to establish flow of informationEffectively and consistently prioritize and delegate daily assignments and projects to the Biologists and Technicians. Ensure that all staff understand, properly prioritize, and execute their assignmentsWrite and distribute concise and effective memos, reports, and communiques as requiredOpenly address internal audit items to the shift in an appropriate and timely mannerCompliance with Policies and RegulationsCompliance with 21 CFR - Parts 210 and 211Compliance with SOPs, batch records, forms, logs of useQualificationsBasic QualificationsBachelor of Science degree or equivalent work experience.Minimum of 4 years of directly related experience.Knowledge of biology and chemistryKnowledge of relevant unit operations.Sterile cell CultureDisposable bioreactors / viral vector manufacturingDisposable clarification / filtration (pharmaceutical unit operations)Ultrafiltration / DiafiltrationSkid operation / column chromatographyBulk Drug Formulation and dilutionSterile Fill / FinishWorking knowledge of desktop computers and technical equipment

Manufacturing Technician-IV

Integrated Resources, Inc

Carlsbad, California

About the Company

Integrated Resources, Inc

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