Senior QC Microbiology Analyst

  • Nationwide
  • Temporary 12 months
  • JO-1711-63016_1510577746

Summary

Responsibilities

* Perform analytical testing as a main priority with efficiency and accuracy

* With a high degree of technical flexibility, work across diverse areas within the lab

* Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.

* Report, evaluate, back-up/archive, trend and approve analytical data.

* Troubleshoot, solve problems and communicate with stakeholders.

* Initiate and/or implement changes in controlled documents.

* Participate in audits, initiatives, and projects that may be departmental or organizational in scope.

* Write protocols and perform assay validation and equipment qualification/verification.

* Introduce new techniques to the lab, including method transfers, reports, validations and protocols.

* Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

* Approve lab results

* May participate in lab investigations.

* May provide technical guidance.

* May train others.

* May contribute to regulatory filings.

* May represent the department/organization on various teams

* May interact with outside resources

Requirements

* Bachelors degree in a science discipline

* Biopharmaceutical QC experience in a microbiology lab

* Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products

* Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.

* Understanding and application of principles, concepts, theories and standards of GMP QC microbiology laboratories. Deepens technical knowledge through exposure and continuous learning

* Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

* Take initiative to identify and drive improvements

* Excellent verbal and written communication skills

* Decision Making skills

* Teamwork and Coaching others

* Negotiation and Influence skills

* Problem solving skills

* Project Management and organizational skills, including ability to follow assignments through to completion

* Technically strong background in microbiology and aseptic manufacturing

* Experience in LIMS, Change Control, Trackwise, SAP and EDMQ an advantage

* Experience with Regulatory inspectors and interacting with inspectors desirable

* Demonstrated ability to work independently and deliver right first time results

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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