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Quality Assurance Specialist

2 months ago

Kingston, Rhode Island, United States Actalent Full time
Job Description

**Job Summary**

We are seeking a highly skilled Quality Assurance Specialist to join our team at Actalent. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our pharmaceutical products by performing physical and chemical analysis of raw materials, in-process, and finished products.

Key Responsibilities:

  • Physical and Chemical Analysis: Perform physical and chemical analysis of raw materials, in-process, and finished products by using analytical techniques such as FT-IR, HPLC, Conductimetry, TOC, and Refractive Index by following the SOPs.
  • Sample Preparation: Prepare samples for analysis involving thorough cleanliness and complex steps for aseptic techniques.
  • Documentation and Record Keeping: Create and maintain laboratory record documentation, update the master control, and prepare the COAs as needed.
  • Investigation and Collaboration: Actively participate in the investigation of Laboratory results, when required. Assist, as and when needed, scientists working in the laboratory.
  • Supply Management: Inform QC Coordinator if chemical or reference standard is expired for removal from laboratory area.
  • Test Solution Preparation: Prepare volumetric test solutions following USP and/or in-house methods for wet chemical tests, standardize such solutions as required, and standardize API for use as in-house reference standard as assigned.
  • Equipment Maintenance and Calibration: Perform this job role in support of laboratory equipment and assumes accountability for the work performed. Actively review reports and documents for compliance with requirements. Assist the Quality Manager in tracking calibration for the laboratory.
  • Purchasing and Document Management: Use the purchasing system to procure laboratory supplies. Actively use the Document Change System to generate or revise documents, as needed.
  • Nonconformance and Quality Improvement: Support the nonconformance system through reporting of nonconformance and supporting Quality in investigation activities. Provides reports and communication based on investigation findings.

Requirements:

  • Wet Chemistry: Proficiency in performing chemical analyses using liquid-based techniques, including titrations, extractions, and precipitation reactions.
  • Method Development and Validation: Experience in creating new analytical methods or modifying existing ones to suit specific requirements, ensuring that a lab can properly operate standard methods before introducing calibrations, and demonstrating that a method meets specific performance characteristics established during the validation study.
  • Calibration and Lab Equipment Maintenance: Regularly calibrate and maintain lab instruments to ensure accurate results.
  • Microbiological Assays: Experience in verifying the absence of viable microorganisms in products or samples, quantifying microbial populations, identifying specific microorganisms, assessing microbial contamination in the lab environment, and analyzing water samples for microbial content.
  • HPLC Analytical Instrumentation: Proficiency in using High-Performance Liquid Chromatography (HPLC) systems for chemical analysis.