Sr Assoc, Microbiology

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

• • To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and to prepare the media, as and when required. To observe the tubes and plates and to supervise the discarding method of the same.
  • To perform periodic microbiological tests as per the schedule, as per Standard Operating Procedure (SOP).
  • To perform the Bacterial Endotoxin Test as per the schedule.
  • To test the material for their pre-sterile bio-burden and to test Raw Material (RM)/ Packing Material (PM) for bio-burden test.
  • To co-ordinate with Technical department for any kind of machine related abnormality, which might be affecting the quality of the product, and its microbiological content.
  • To take the samples for sterility test and to carry out the sterility testing as per schedule.
  • To sign all the documents related to microbiological testing.
  • To sign the documents related to sterility testing. To analyze water samples for pH, conductivity, Bacterial Endotoxin Test (BET), bio-burden, Total Organic Carbon (TOC), bio- assay, pathogens, Thermopiles, chlorides, hardness, silt density index etc.
  • To analyze the samples of water system after maintenance work and forward the report to executive of department for review.
  • To maintain and update stock record of Limulus Amoebocyte Lysate (LAL) reagents.
  • To qualify the personnel to enter in to the clean. To keep track of requirement for procurement and give monthly requirement to executive.
  • To qualify the prepared media for growth promotion test. To perform gram staining of daily-observed colonies and identify them on BBL crystal.
  • To perform the microbiological analysis of stability sample as per daily plan of work & in line with standard operating procedure.
  • To prepare Contact plate for routine monitoring. To perform the validation as per the laid down protocol.
  • To prepare pure culture for routine use. To maintain and update media stock record formats.
  • To record all the data related to microbiological testing.
  • To prepare requirement list of media & reagent for procurement.
  • To intimate executive for any abnormalities in microbiological analysis. However, in the absence of executive, intimate the status of the same to Department Head.
  • To ensure the clean environment for sterile preparation by implementing the Good Manufacturing Practice (GMP) norms as per the international standards and guidelines.
  • To do sampling of Water for Injection (WFI), double Reverse Osmosis (DRO), Single Reverse Osmosis (SRO), raw water and pure steam.
  • To collect the validation samples as per validation protocol
  • To prepare trends of the results obtained
  • To qualify the personnel to enter in to the clean room.
  • To perform HEPA filter qualification on periodic basis and as and when required
  • To operate laboratory instrument or equipment as and when required.
  • To initiate non-conformity or Out of Specification in case of abnormality observed.
  • To perform data entry for trend analysis of the daily result observed.
  • To communicate any failure or abnormal notification to respective Supervisor for their attention and to seek the solution.
  • To bring to the notice of Supervisor about the abnormalities in the clean room or manufacturing areas and suggest the preventive and corrective measures in case of such abnormalities as per the guideline.

  Skills Required- Functional/Behavioral:

  Aseptic Processing and Sterile Product Processing Technologies Ability to Exchange Constructive Feedback Product and Process Familiarity QMS Events Quality Systems and GMP Compliance Knowledge Regulatory Knowledge and Liaison Understanding.

Reasonable Accommodations

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