Description:

　　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.

　　• 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 nonconformance's 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

　　Additional Skills & Qualifications:

　　• Requires BS in Chemistry or other Physical Science

　　• 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

　　Diversity, Equity & Inclusion

　　At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

　　Hiring diverse talent

　　Maintaining an inclusive environment through persistent self-reflection

　　Building a culture of care, engagement, and recognition with clear outcomes

　　Ensuring growth opportunities for our people

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.