Microbiologist QC

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PharmaLex is a highly successful and growing consulting company for the Healthcare industry. PharmaLex offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

General Description:

We are seeking seasoned consultants who can provide support as Microbiologist (QC Analyst). The person will be responsible for performing various microbiological analyses to evaluate the quality of raw materials, in-process materials, and finished goods to ensure compliance with established standards.

Key Responsibilities And Activities

• Conducts all activities (including assays) per applicable GxP and according to appropriate SOPs and Pharmacopeia.
• Conducts routine and non-routine microbiological analyses of in-process materials, raw materials, environmental samples, finished goods, or stability samples.
• Reports assays results following GLP and appropriate SOPs.
• Participates in internal assessments and support external audits as required.
• Identifies and troubleshoot equipment problems.
• Serves as a technical liaison between quality control and other departments, vendors, or contractors.
• Writes technical reports or documentation to support deviation reports, testing protocols, and trend analyses.
• Writes or revise standard quality control operating procedures.
• Supplies quality control data necessary for regulatory submissions.
• Participates in out-of-specification and out-of-trend investigations and recommend corrective actions.
• Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release.
• Completes documentation needed to support testing procedures including data capture forms, equipment logbooks, or inventory forms.
• Calibrates, validates, or maintains laboratory equipment.
• Ensures that lab cleanliness and safety standards are maintained.
• Trains other analysts to perform laboratory procedures and assays.
• Other duties as required.
  
  

Requirements

• B.S. in scientific discipline or related field
• 5-7 years working within a pharmaceutical Microbiology laboratory or associated discipline
• Familiarity with USP , USP , USP testing requirements
• 3-5 years of experience on the bench performing endotoxin, bioburden, TOC, microbial identifications and related assays
• Previously performed technical review of microbiological testing data
• Familiarity with Pyros, Vitek Maldi-Tof, MODA, Labvantage, DataPro is preferred
• Ability to assesses non-conformances and elevate issues appropriately
• Ability to coordinate effectively with analysts to ensure timeliness of corrections or necessary remediation activities
• Able to detect trends in documentation errors and implement appropriate retraining / corrective actions
  
  

PharmaLex is an Equal Opportunity Employer.

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