Senior QC Analyst

Job Description

Business: Piramal Pharma Solutions
Department: Quality Control
Location: Sellersville
Travel: N/A

Job Overview

Performs Analytical chemistry examination testing on raw materials, finished products or stability samples in accordance with approved Standard Operating Procedures (SOPs) and valid methods. This is a safety-sensitive position.

Key Responsibilities

• Chemical or Physical testing analysis of raw materials, finished products, stability or request samples
• Documenting and submitting all raw data and results in LIMS
• Preparation of reagents for chemical analysis including peer review
• Knowledgeable in compendial (USP/EU) testing requirements and ensuring compliance per FDA 21 CFR

Competencies

• Strong understanding of laboratory safety practices and PPE
  • Expectation of zero safety observations
• Strong understanding of cGMP
  • Minimal to no laboratory errors are expected.
• Strong understanding of good documentation practices
  • Minimal corrections/errors expected.
• Strong understanding of compendial testing requirements
  • Additional understanding of international compendiums such as EP
• Expected to train other analysts.
• Coordinates communication and interactions with outside vendors and clients for the laboratory.
• Responsible for technical documentation such as protocols, reports, specifications, and laboratory investigations.
• No supervision necessary from management.
• Expected knowledge of balance, FTIR, dissolution, UV-VIS, Karl Fischer, pH, wet chemistry techniques, reagent preparation, volumetric solutions, GC, PSD, Malvern, XRD, and able to handle independent HPLC testing such as Assay, Blend Uniformity, Impurity Analysis, Dissolution, Content Uniformity.
• Able to perform assigned task from start to finish independently without error. Including standard, sample, and reagent preparation through data processing and submission.
• Willing and able to provide guidance to other analysts as needed.

Experience

• Bachelor's degree in chemistry, biology, microbiology or other related science with relevant laboratory coursework is required.
• 5 years laboratory experience, preferably in a GMP environment
• Wet Chemistry testing, Balance, Dissolution, FTIR, KFM, UV/Vis, Titrations, Viscosity, PSD testing, pH, conductivity
• Proficiency with computer software such as MS Word, Excel, or PowerPoint
• Excellent organizational skills and attention to detail.
• Excellent at multitasking, handling multiple projects at one time, and changing priorities based on business needs.
• Self-driven and motivated.
• Excellent problem solving skills.
• Excellent interpersonal and communication skills.
• Time management skills.