MICROBIOLOGIST (QC ANALYST)
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.Required Education And Experience
Key Responsibilities And Activities
- 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
- 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.
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