Analyst II, QC Raw Materials

About the Role

This is an on-site laboratory testing position with major responsibilities including daily testing, quality systems support, and inter-departmental scientific support. The role involves working on complex and varied problems/projects requiring in-depth analysis and interpretation.

Responsibilities

• Sample, label, test, send for external testing, and release incoming raw materials using LIMS.
• Support laboratory operations through maintenance of laboratory, equipment, and test methods per approved procedures.
• Own and drive to completion:
  • Quality notifications and tasks in the quality management system (deviations, CAPA, Change Controls, Effectiveness Checks).
  • Creation of new documents and document updates.
  • Performance of material qualification tasks (testing, report generation).
• Demonstrate proficiency in simple methods (e.g., physical inspection, pH, dimensional analysis, appearance) and moderately complex methods (e.g., FTIR, Titration, UV Vis Spectrophotometry, Gel Electrophoresis, HPLC, Loss on Drying).
• Follow written procedures and execute laboratory methods, including wet chemistry techniques.
• Use LIMS to manage samples and document testing results.
• Execute laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
• Investigate and determine root cause associated with laboratory deviations.
• Execute Change Controls, CAPAs, and Effectiveness Checks.
• Execute validation studies; obtain and interpret validation data.
• Maintain laboratory equipment as per established procedures.
• Initiate change and continuous improvement using LEAN practices such as 5S and Kaizen.
• Work with facilities/metrology to conduct and document execution of work orders to ensure GMP-compliant state of labs and equipment.
• Use GMP and scientific expertise to lead internal (department and site) audit activities.
• Perform as supporting personnel and/or act as lead under guidance of management or higher-level scientific personnel.
• Provide guidance to lower-level personnel.
• Perform laboratory instrument calibration in accordance with established procedures.
• Represent QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
• Perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.
• Review and verify QC data.
• Author/revise and contribute to test methods, SOPs, specifications, protocols, technical studies, or reports.
• Author laboratory investigations and non-conformance reports.
• Support CAPA and change control through participation in project planning and collaboration.
• Work on problems of diverse scope requiring evaluation of identifiable factors.
• Exercise judgment within defined procedures and practices to determine appropriate action.
• Follow good laboratory practices and procedures in analyzing situations or data.

Requirements

• Bachelor’s or master’s degree in an applied science (chemistry preferred).
• 3–5 years of experience preferred, or equivalent level of skill and experience.
• Previous hands-on experience with raw material assays in a GMP manufacturing environment is preferred.
• Understanding of cGMP, CFR, and USP is required.
• Proficiency in computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications.
• Good written and verbal communication skills, and teamwork skills.
• Personal competencies: self-awareness, integrity, team player, innovative, and flexible.

Pay

The estimated annual base salary as a new hire for this position ranges from $70,500 to $70,300. Individual base pay depends on various factors such as applicant’s education, experience, skills, and abilities, as well as internal equity and alignment with market data. The salary may also be adjusted based on applicant’s geographic location. Certain roles are eligible for additional incentive compensation, including merit increases, annual bonus, and/or long-term incentives in the form of stock options.

Benefits

Emergent offers a comprehensive benefits package. Eligibility for benefits is governed by the applicable plan documents and policies. Additional information can be found here.