QC Analyst II

Summary of Responsibilities:

The Quality Control Analyst II is primarily responsible for the activities and procedures which are required to sample and test raw materials, work-in-process samples, finished goods, and stability samples under cGMP conditions. The position follows established procedures in the execution of daily activities and completes required documentation.

Strategic Focus Areas:

Effectively collaborates with internal colleagues to meet corporate objectives and drive business results. Demonstrates business and Quality Control knowledge.

Specific Responsibilities:

• Testing of incoming raw material according to USP, EP, or ACS Reagent Index
• Performance of QC analytical chemistry assays, HPLC, GC & GC/MS, Headspace, Moisture analyzer, Karl Fisher as well as wet chemistry assays.
• Testing of in process and release manufacturing samples, stability samples and Engineering/R&D samples using the following instrumentation/techniques:
• HPLC
• GC & GC/MS
• UV/Vis Spectrophotometry
• FTIR Spectrophotometry
• Auto & Manual Titrations
• Freezing Point & Vapor Pressure Osmometry
• Absolute Viscosity using Brookfield Cone/Plate Viscometer
• Intrinsic Viscosity using Ubbelohde Tube and Dilute Solution Viscometer
• pH Meter
• TOC Analyzer
• Conductivity Meter
• Complete required documentation for all work activities according to Good Documentation Practices; reviews lab notebooks and verifies results of other Analysts
• Collaborates with R&D to develop test methods for new products Performance of QC method qualification, validation and transfers
• Researches and optimizes Test methods according to accepted industry best practice; performs qualification and validation of methods
• Report procedural deviations and nonconformances to management; preforms investigations as assigned and follows through to closure of corrective action
• Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required
• Performance of QC general laboratory equipment maintenance
• Participate in other projects as assigned
  
  

Job Complexity:

The position works on problems of moderate scope in which analysis of situation or data requires review of variable factors. Exercises judgement within defined procedures and practices to determine appropriate action and receives detailed instructions on new projects or assignments.

Supervisory Responsibilities:

None

Required Qualifications:

• Requires BS in Chemistry or other Physical Science or equivalent experience.
• 2 – 5 years testing experience in FDA regulated pharmaceuticals or medical device industries
• Demonstrated experience with GMP/ ISO regulations
• Proficient in HPLC, GC analyses and prior experience in method development and method validation.
• Demonstrated experience with basic lab instrumentation including UV/vis and FTIR spectrophotometers, pH Meters, and Osmometers
• Skilled in various wet chemistry techniques such as titrations and compendial ID testing
• Constantly strives to exceed goals, requirements, accomplishments and expectations
• Ability to work flexible hours to complete work activities
  
  

Desired Experience, Knowledge, and Skills:

• Experience with Viscometers, HPLC, GC, GC/MS, TOC Analyzers, or Conductivity Meters
• Experience in a results driven, team environment
• Ability to handle multiple priorities and meet established deadlines
• Experience maintaining spreadsheets and preparing simple graphing is preferred