3 days left

Aurobindo Pharma USA, Inc.
Hightstown, New Jersey, US
Apr 28, 2021
Jun 19, 2021
Employment Type
Full time
Salary Type
Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10 year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has give Aurolife a jump start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.

Microbiologist will perform a variety of Microbiology testing to assess the strength, identity and purity of test samples and/or materials. The Microbiologist will work as a member of team to effectively plan and Microbiology testing using established (official in USP and/or in-house) test procedures. The Microbiology may execute 90% - 100% of their work at the bench level.

  • Preparation of SOP and ensuring of their implementation.
  • Provide microbiological sampling, testing, Method Validations and monitoring to assure quality of materials, components, in-process products, finished products, and retained/stability samples, including:
  • Media Preparations
  • Plate Observations
  • Colony identification
  • Isolate Library
  • Culture Prep and Maintenance
  • BET testing
  • Sterility testing
  • Growth promotion testing (GPT)
  • Water / Bioburden testing / MLT / Identification for Microorganisms.
  • Environmental Monitoring / Cleaning / Validation, etc
  • preparation of Microbiological method development and method validation procedures like BET Sterility, MLT, BIO Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation.
    • Microbiological data Review, summary preparation (trend data, text reports and validation data) and Approval of documents and Procedures.
    • Report, investigate, and resolve any QMS incidents in the process, system, facility or documents associated with non-conformances related to the microbiological aspects such as sterility, bioburden, endotoxin, environmental monitoring, etc
    • Procurement of Laboratory needs (Laboratory Indent) and qualification of vendors.
    • Preparation of validation Protocols and Execution of the same.
    • Involvement and execution of process simulation studies (Aseptic media fill).
    • To ensure the process of Technology Transfer Dossier (TTD) acceptance to the plant and to work out the manufacturing and availability of the product without delays.
    • Schedule training and qualification of production personnel and their record maintenance.
    • Handling of OS and OOT.
    • Implementation of QMS (Change Management and deviation management in coordination with QA department.
    • Execution of equipment and area qualifications.
    • Internal inspection for audit compliance.
    • Perform troubleshooting and investigations under the direction of a supervisor.
    • Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.

    Microbiological method development and method validation procedures like BET, Sterility, MLT, BIO Assay and Disinfectant qualification and microbiological hold time validation, Container closure integrity validation.

    Master of Science

    Up to 3 years experience preferred

    FIELD - While performing the duties of this job the employee is required to: • Work in a temperature controlled office environment or travel via vehicle or commercial transportation • While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment • Position requires some degree of travel for business purposes • Employee may use computer, phone, copier and other office equipment in the course of a day • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.
    No Additional Requirements
    Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
    Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

    This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

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