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Quality Control Analyst, Microbiology
Description
QC Lab Analyst: Microbiologist
Responsible for conducting analysis of raw materials, mass and cosmetic finished goods, in accordance with specifications and standards, before being shipped or used in filling or manufacturing. Working in the QC Microbiology Laboratory, prepare media, carry out growth promotion testing or any specialized testing as required. Perform environmental monitoring testing and validation. Inform management of critical issues and perform OOS lab investigations Deviations, CAPA, protocol execution and follow standard operating procedures and protocols. Wearing PPE and following procedure and safety guidelines is a prerequisiteKEY ROLES & RESPONSIBILITIES Execution of QC Lab Testing
- Accountable for completing training related to all tests being performed in lab and general housekeeping.
- Monitor Critical Control Parameters (lab process water, pH, balance) through daily equipment verification checks and alert QC lab manager of any out of trend events.
- Perform QC Microbiology Testing/ analysis of raw materials, mass and finished goods and reportresults. This includes responsibility for sample preparation, testing, analyzing and entering results into SAP/LIMS and preparation of CoAs.
- Perform environmental monitoring testing, sampling and support validation execution.
- Perform documentation as needed to support testing procedures.
- Work with Lab Coordinator to retain or discard samples, archive lab documents.
- Prepare media and growth promote media.
- Use all Lab equipment; perform safety checks and check expiry following procedures and maintaining all equipment by checking status before and after each use.
- Help with inventory management and forecast consumables within lab for testing to ensure that these are replenished in a timely manner.
- Do SOP review and/or test peer review and elevate all non-conformances immediately to management.
- Perform identification of organism, gram stain and microscopy.
- Help maintain good housekeeping.
Testing Data Review - Data Reviewer role responsibilities
- Review of routine/non-routine supporting test data and results, including sample preparation records, logbooks, calculations, and data sheets. Enter results in SAP/LIMS, as needed.
- Review of all raw data including but not limited to C of A of all consumables and logging and filing of data and raw data.
Investigation
- Identify quality problems & elevate to leadership
- Independent decision making ability required in straight forward situations
- Perform Phase 1 OOS laboratory investigations with guidance from senior lab analysts
- Conduct Quality Control evaluations of consumer complaints and Quality Inquiries
- Write up change controls/CAPA follow up / deviation execution and investigation
- Perform duties as assigned by management
Qualifications
Education: Minimum Diploma in sciences (Microbiology or Biotechnology)Experience: Applicable work experience
Additional Job Specifications:
- Experience in a microbiology, or product evaluation laboratory in Quality Control for a global consumer goods or pharma company
- Microbiology evaluation skills preferred with emphasis on Testing, reading of test plates, counting colonies and describing colony morphology etc.
- Awareness and practice of safe lab procedures
- Knowledge of laboratory testing techniques (GMP, GDP and Good Lab Practices) and proficient use of all laboratory equipment
- Proficient oral and written communication skills and ability to appropriately communicate information to management
- Ability to write SOPs, deviations, change controls and OOS reports
- Problem solving skills
- Knowledge of cosmetic ingredients & manufacturing procedures preferred
- Proficiency in Microsoft Office Suite and SAP systems is preferred
- Must be flexible to work different shifts and overtime as needed
- Must be able to lift 35 lbs and climb step ladder if needed
- Must be able to travel to Hillmount site as needed