Analyst II, QC Raw Materials

Emergent BioSolutions•Canton, MI

1d•Onsite

About The Position

This is an on-site laboratory testing position with the major responsibilities being daily testing, quality systems support, and inter-departmental scientific support. Works on complex and varied problems/projects requiring in depth analysis and interpretation. Sample, label, test, send for external testing, and release of incoming raw materials utilizing LIMS. Support laboratory through the 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). Has understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU). Demonstrates proficiency in simple methods such as physical inspection, pH, dimensional analysis and appearance and moderately complex methods such as FTIR, Titration, UV Vis Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying. Ability to follow written procedures and execute laboratory methods including wet chemistry techniques. Experience using LIMS to manage samples and document testing results. Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers. Ability to Investigate and determine Root Cause associated with laboratory deviations. Executes Change Controls, CAPAs, and Effectiveness Checks Executes validation studies; obtain and interpret validation data. Maintains laboratory equipment as per established procedure. Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen. Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment. Uses GMP and scientific expertise to lead internal (department and site) audit activities. Performs as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel. May provide guidance to lower level personnel. Performs laboratory instrument calibration in accordance with established procedures. Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration. May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times. Reviews and Verifies QC data. Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports. Author laboratory investigations and non-conformance. Supports CAPA and change control through participation in project planning and collaboration. Works on problems of diverse scope requiring evaluation of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained Receives no instruction on routine work, general instructions on new assignments.

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.
An understanding of cGMP, CFR, and USP is required.
Require good written and verbal communication skills, good teamwork skills
Computer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required.

Nice To Haves

Has understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
Demonstrates proficiency in simple methods such as physical inspection, pH, dimensional analysis and appearance and moderately complex methods such as FTIR, Titration, UV Vis Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.
Ability to follow written procedures and execute laboratory methods including wet chemistry techniques.
Experience using LIMS to manage samples and document testing results.
Ability to Investigate and determine Root Cause associated with laboratory deviations.
Executes Change Controls, CAPAs, and Effectiveness Checks
Executes validation studies; obtain and interpret validation data.
Maintains laboratory equipment as per established procedure
Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
Uses GMP and scientific expertise to lead internal (department and site) audit activities.
Performs as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel.
May provide guidance to lower level personnel.
Performs laboratory instrument calibration in accordance with established procedures.
Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.
Reviews and Verifies QC data.
Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
Author laboratory investigations and non-conformance.
Supports CAPA and change control through participation in project planning and collaboration.
Works on problems of diverse scope requiring evaluation of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained
Receives no instruction on routine work, general instructions on new assignments.
self-awareness, integrity, team player, innovative, and flexible.

Responsibilities

Sample, label, test, send for external testing, and release of incoming raw materials utilizing LIMS.
Support laboratory through the 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)
Executes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.
Ability to Investigate and determine Root Cause associated with laboratory deviations.
Executes Change Controls, CAPAs, and Effectiveness Checks
Executes validation studies; obtain and interpret validation data.
Maintains laboratory equipment as per established procedure
Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.
Works with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.
Uses GMP and scientific expertise to lead internal (department and site) audit activities.
Performs as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel.
May provide guidance to lower level personnel.
Performs laboratory instrument calibration in accordance with established procedures.
Represents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.
May perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.
Reviews and Verifies QC data.
Author/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.
Author laboratory investigations and non-conformance.
Supports CAPA and change control through participation in project planning and collaboration.
Works on problems of diverse scope requiring evaluation of identifiable factors.
Exercises judgment within defined procedures and practices to determine appropriate action.
Follows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained
Receives no instruction on routine work, general instructions on new assignments.
Actively participate in self-development
Follow through on commitments, Situational Leadership or additional accountability tools
Able to complete required tasks and associated documentation with minimal error
Maintain positive attitude in a changing work environment
Effectively communicate with all levels of manufacturing and support staff
Actively participate in department / level meetings
Escalate issues through the proper channels
Live the Core Values