Analyst II, QC Raw Materials

Location
Canton, MA, US
Posted
Jan 27, 2021
Ref
708602800
Required Education
Bachelors Degree
Position Type
Full time
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

This is a 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 FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Overview:
  • Sample, label, test, send for external testing, and release of incoming raw materials.
  • 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)


Technical Expertise:
  • Has core understanding of applicable compliance/guidance/regulations (ISO, USP, FDA, EU).
  • Demonstrates proficiency in moderately complex methods such as FTIR, Titration, UV Vis Spectrophotometry, Gel Electrophoresis, HPLC, and Loss on Drying.
  • 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


Laboratory Support (Including Quality Systems):
  • 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.

Quality Systems:
  • 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.

Problem Solving:
  • Works on problems of diverse scope requiring evaluation of identifiable factors.
  • Exercises judgment within defined procedures and practices to determine appropriate action.
  • Receives no instruction on routine work, general instructions on new assignments.

Behavior/Cultural Responsibilities:
  • Ownership - Actively participate in self-development
  • Accountability - Follow through on commitments, Situational Leadership or additional accountability tools
  • Detail oriented - Able to complete required tasks and associated documentation with minimal error
  • Adaptability - Maintain positive attitude in a changing work environment
  • Communication - 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

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
  • 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.
  • Personal Competencies: self-awareness, integrity, team player, innovative, and flexible.
  • 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.

There 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.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions' approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions' approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

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