JOB SUMMARY

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.

ESSENTIAL

FUNCTIONSReasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.\n

Overview:

Sample, label, test, send for external testing, and release of incoming raw materials utilizing LIMS.\nSupport 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\nPerformance of material qualification tasks (testing, report generation)

Technical Expertise:

Has understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).\nDemonstrates proficiency in simple methods such as physical inspection, pH, dimensional analysis and appearance and moderately complex methods such as FTIR, Titration, UV Vis\nSpectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.\nAbility to follow written procedures and execute laboratory methods including wet chemistry techniques.\nExperience using LIMS to manage samples and document testing results.\nExecutes laboratory tests and other lab activities to ensure timely delivery of results to internal and external customers.\nAbility to Investigate and determine Root Cause associated with laboratory deviations.\nExecutes Change Controls, CAPAs, and Effectiveness Checks\nExecutes validation studies; obtain and interpret validation data.\nMaintains laboratory equipment as per established procedure Laboratory Support (Including Quality Systems): Initiates change and continuous improvement using LEAN practices such as 5S and Kaizen.\nWorks with facilities/metrology to conduct and document execution of work orders to ensure GMP compliant state of labs and equipment.\nUses GMP and scientific expertise to lead internal (department and site) audit activities.\nPerforms as supporting personnel and/or acts as lead under guidance of management or higher-level scientific personnel.\nMay provide guidance to lower level personnel.\nPerforms laboratory instrument calibration in accordance with established procedures.\nRepresents QC in vendor relations, including contract support and working with vendors during validation (IOPQ) and calibration.\nMay perform scheduling to ensure critical QC metrics are consistently met for product turnaround times.

Quality Systems:

Reviews and Verifies QC data.\nAuthor/revise and contributes test methods; SOPs; specifications; protocols, technical studies or reports.\nAuthor laboratory investigations and non-conformance.\nSupports CAPA and change control through participation in project planning and collaboration.

Problem Solving:

Works on problems of diverse scope requiring evaluation of identifiable factors.\nExercises judgment within defined procedures and practices to determine appropriate action.\nFollows good laboratory practices and procedures in analyzing situations or data from which answers can be readily obtained\nReceives no instruction on routine work, general instructions on new assignments.

Behavior/Cultural Responsibilities:

Ownership

Actively participate in self-development\nAccountability
Follow through on commitments, Situational Leadership or additional accountability tools\nDetail oriented
Able to complete required tasks and associated documentation with minimal error\nAdaptability
Maintain positive attitude in a changing work environment\nCommunication
Effectively communicate with all levels of manufacturing and support staff\nActively participate in department / level meetings\nEscalate issues through the proper channels\nLive the Core Values The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties.

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

Due to the nature of this role and our manufacturing environment, employees are required to meet certain health and safety requirements, including the ability to adhere to the Company's vaccination policies where job-related and consistent with applicable law. We are committed to providing a fair and inclusive hiring process and will evaluate reasonable accommodation requests for medical disabilities, or sincerely held religious beliefs, in accordance with applicable laws.\nBachelor's or master's degree in an applied science (chemistry preferred).\n3

5 years of experience preferred, or equivalent level of skill and experience.

\nPrevious hands-on experience with Raw Material assays in a GMP manufacturing environment is preferred.\n

Personal Competencies:

self-awareness, integrity, team player, innovative, and flexible.\nAn understanding of cGMP, CFR, and USP is required.\nRequire good written and verbal communication skills, good teamwork skills\nComputer skills (MS Office, MS Excel, MS Project) or comparable word-processing and spreadsheet applications is required. U.S. Base Pay Ranges and Benefits Information\nThe 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.]\nAdditionally, Emergent offers a comprehensive benefits package

. Information regarding additional benefits can be found here: https://www.emergentbiosolutions.com/careers/life-at-emergent (
Eligibility for benefits is governed by the applicable plan documents and policies).

\nIf you are selected for an interview, please feel welcome to speak to a Human Resources Partner about our compensation philosophy and available benefits.\nThere are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.\nReasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.\nEmergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. 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