Quality Scientist Job Description

Quality Scientist Job Description

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Quality scientist provides training to staff in technical areas dealing with emission inventory development, air dispersion modeling, air quality assessment guidance, and in policy areas dealing with the interpretation of CEQA, NEPA, and emerging regulatory issues.

Quality Scientist Duties & Responsibilities

To write an effective quality scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included quality scientist job description templates that you can modify and use.

Sample responsibilities for this position include:

Familiar with standard chemistry concepts, practices & procedures
Performs a variety of assignments within the QC Chemistry lab in support of assigned plant operations to ensure the highest standards are met for products
Develop, revise and author complex, explicit documentation, new and current procedures, validation protocols and technical reports incorporating appropriate use of statistics
Will effectively perform a multitude of laboratory techniques for which they are trained on with minimal error
Provide input to project teams on project specific processes and deliverables
Provide testing, technical and troubleshooting support in the Quality Control laboratories
Handle the collection, processing, method development and testing of chemical components, bulk products, raw materials, packaging components, finished products, marketed product stability, in-process materials, scale up, validation and cleaning validations to conform with specifications and standard operating procedures (SOPs)
Perform statistical analysis in support of APRs, Stability, and Product Release
Possess foresight to recognize task needs and performs the trained task without the request of management
Possess thorough knowledge of SOPs, USP and other applicable pharmacopeia

Quality Scientist Qualifications

Qualifications for a job description may include education, certification, and experience.

Licensing or Certifications for Quality Scientist

List any licenses or certifications required by the position: EIT, HAZWOPER, GFSI, QSTI, ASQ, QSP, CWA, OSHA, IVD, CE

Education for Quality Scientist

Typically a job would require a certain level of education.

Employers hiring for the quality scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Science, Chemistry, Biology, Engineering, Biochemistry, Technical, Microbiology, Life Science, Education, Biotechnology

Skills for Quality Scientist

Desired skills for quality scientist include:

Excel
Basic GLP requirements
NEPA assessment requirements
Powerpoint
Good Manufacturing Practices for pharmaceutical manufacturing
Chemistry
CGMP/GLP requirements
Corporate
Microsoft Word
Air Pollution Control District regulatory programs and their application in CEQA/NEPA analyses

Desired experience for quality scientist includes:

A degree in microbiology or related science is required
2+ years’ experience in FDA regulated industry is required
Knowledge and experience in microbiological methods is required
Knowledge of GMPs, GLP, FDA, and OSHA knowledge is preferred
Previous experience with CAPA is preferred
Individual must be familiar with basic scientific principles and has had some laboratory experience

Quality Scientist Examples

1

Quality Scientist Job Description

Job Description Example
Our growing company is hiring for a quality scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality scientist
  • Reviewing clinical batch records and processing and formatting site controlled documents in an eDMS system
  • Use electronic systems to accomplish work tasks assigned such as OpenLab, LIMS, SAP, SCORE, ValGenesis or other electronic systems
  • Collaborate with internal and external department contacts and other business partners to ensure required inputs support site priorities and meet cGMP requirements, within established timelines
  • Work on assignments that are routine in nature where ability to recognize deviation from accepted practice is required
  • Engages with quality and R&D networks the business units to effectively promote and drive sterilization innovation goals aligned to the company’s mission and vision
  • Proactively identify and work through obstacles that may hinder the delivery of individual impact goals
  • Ensure all sterilization innovation activities are sufficiently resourced and compliant with applicable regulations and procedures
  • Continuously evaluate departments/plants/business progress toward tactical goals and objectives adapting them to meet customer and business needs
  • Pursue and actively manage key stakeholder relationships that support the broader strategy that are impacted by department/plant/business goals
  • Development and implement best quality practices
Qualifications for quality scientist
  • The ability to follow written direction and maintain a laboratory notebook is required
  • Good communication skills and computer literacy are required
  • Must be able to move 20 lbs., and perform job tasks with reasonable accommodation
  • An understanding of lab safety involving bio-waste is required
  • A strong “Team-Player” orientation is preferred
  • This position is located in Irvine and CA, and may require minimal travel
2

Quality Scientist Job Description

Job Description Example
Our company is hiring for a quality scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality scientist
  • Applies ANSI, AAMI, ISO, USP, EU, EPA and related regulations toward sterile product and sterilization process design
  • Evaluate, including raw material review and product design, the feasibility of nontraditional sterilization technologies
  • Independently design experiments, deduce conclusions and calculate acceptance criteria
  • Maintain qualitative and quantitative analysis, include deviations and exceptions
  • Review investigations of testing anomalies and approve corrective actions
  • Manage and lead a variety of projects with a focus on stormwater regulatory compliance, flood mitigation and protection, urban drainage designs, streambed protection, urban storm water management, water quality modeling, regulatory compliance, low-impact development (LID) design, and green infrastructure
  • Specialize in the preparation of technical reports such as Jurisdictional Runoff Management Plans, Water Quality Technical Reports, CEQA/NEPA documents, and Storm Water Pollution Prevention Plans (SWPPPs) for construction and industrial applications
  • Assist or manage the preparation of proposals, and provide creative project approaches through written, verbal, and graphic communication
  • Project work could include small- and large-scale infrastructure projects for natural and urban environments focused on stormwater management systems, green infrastructure, sustainable stormwater, and ecosystem restoration
  • Review of site documentation
Qualifications for quality scientist
  • B.E./B.S
  • Knowledge of the following industry regulations (FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) / QSR (Quality System Reguation), ISO (International Organization of Standardization)
  • Knowledge of cGMP (Good Manufacturing Practice) practices
  • Knowledge of PC spreadsheet, word processing, and database applications
  • Bachelor's Degree in Biology, Microbiology or other related Life Science is required
  • Requires a minimum of 3 years of work experience in an R&D or Quality Control Laboratory
3

Quality Scientist Job Description

Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of quality scientist. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for quality scientist
  • Able to review and approve executed validation records and deviations under limited guidance/coaching
  • Utilize method 1, yellow belt tools to address simple problems and continuous improvement ideas under limited guidance/coaching
  • Provide support and assistance to Section and Project Managers, as requested, in administrative functions, and provide suggestions to improve efficiency and effectiveness
  • Evaluates the chemical properties of various organic, inorganic & biochemical substances in order to investigate their application and/or suitability for use
  • Accountable for the accurate and timely completion of all activities related to Testing and Projects
  • Handles hazardous materials, including chemicals and infectious agents in the proper manner as established by safety and company policy
  • Orders and prepares reagents, materials, formulations, laboratory supplies and equipment and maintains sufficient inventories so as to prevent delays in project schedules
  • Assists in documentation writing & revising including vendor specifications, raw material specifications, Test methods, final product specifications, SOPs, as required
  • Assists in completing project protocols, change notifications, deviation waivers and Quality Notifications with only moderate supervision
  • Supports satellite facilities other internal disciplines with customer requests and complaints
Qualifications for quality scientist
  • Prefer a minimum of 3 years of sterilization experience
  • Demonstrated knowledge of and ability to apply cGMP regulations
  • Other various ‘mad skills’ are a plus
  • Through understanding of manufacturing process records content or testing records
  • Excellent technical writing skills including experience with SOPs and document review processes
  • Experience in a regulated, GMP or GLP environment
4

Quality Scientist Job Description

Job Description Example
Our growing company is searching for experienced candidates for the position of quality scientist. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for quality scientist
  • Undertakes additional duties as assigned
  • Entry level food scientist 0-5 years’ experience
  • Data analysis and use of various tools such as ProMax, ACTS, Spotfire, ArcMap GIS
  • May include auditing, risk assessments, air emissions modeling
  • Participating with senior managers to leverage and develop client relationships to build long-term business partnerships and effective relationships with regulatory personnel
  • Participating with senior team members in key stakeholder forums and industry groups
  • Depending on candidate qualifications, support other environmental health and safety compliance projects in Oil & Gas and other industrial sectors
  • An anticipated 25% travel for field work if required for project delivery
  • Flexibility and a passion to drive for results are key for this position
  • The ideal candidate is well versed in various analytical techniques such as Flow Cytometry, ELISAs, PCR, and cell bioassays and other applicable methods to the testing of biopharmaceuticals products
Qualifications for quality scientist
  • Knowledge of LIMS or stability software is a plus
  • Ability to demonstrate a broad familiarity with air sampling and analysis instrumentation for the collection and measurement of criteria pollutants, VOCs, carbonyls, SVOCs such as PAHs, and particulate matter (PM10, PM2.5, speciated PM, UFP)
  • Excellent writing, communication, interpersonal skills, analytical, and leadership skills
  • Ability to travel domestically, including participating in field work, approximately one week per month
  • Knowledge of Immunoassay product lines
  • Bachelors of Science degree required with a minimum of 5 years of relevant experience or a combination of education and experience
5

Quality Scientist Job Description

Job Description Example
Our company is searching for experienced candidates for the position of quality scientist. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for quality scientist
  • Plans and performs quality control testing of reagents and kits utilizing the ION Torrent platform, HPLC, qPCR and mass spec
  • Collects and analyzes data for final disposition using preapproved documentation troubleshoots assays
  • Serve as Quality Control Subject Matter Expert across all three functional QC groups
  • Assist QC Supervisors with managing QC schedules
  • Train new and existing QC scientist on new and existing Quality Control test methods
  • Performs and documents equipment maintenance
  • Update QC test methods, QBR’s, forms, and SP’s to align with current laboratory practices and improvements
  • Write and execute stability protocols and reports
  • Instrument start up
  • Perform and document equipment maintenance
Qualifications for quality scientist
  • Proven experience in IQ, OQ & PQ trouble shooting and problem solving for EO, Gamma, eBeam, or another sterilization technology
  • Independent ability to identify, isolate, and study microorganisms
  • Proven experience with process challenge devices
  • Professional certification(s) related to stormwater compliance (CPESC, CPSWQ, CESSWI, CMS4S, QSP/D, QISP, ToR)
  • Strong working knowledge of federal, state, and local (San Diego) environmental legislation and regulations with focus on stormwater and water quality/hydrology
  • Excellent organizational, technical writing, and verbal communication skills

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