QC Scientist Job Description
QC scientist
provides input into the development of analytical/microbiological methods, specifications, testing protocols, SOPs and regulatory documents (NDAs, sNDAs, MAAs, etc.).
QC Scientist Duties & Responsibilities
To write an effective QC scientist job description, begin by listing detailed duties, responsibilities and expectations. We have included QC scientist job description templates that you can modify and use.
Sample responsibilities for this position include:
Data entry and verification on LIMS
Preparation of drug product and drug substance CoA
Analysis and trending of analytical data sets
Leading laboratory OOS and OOT investigations
Generation and maintenance of dept KPIs
Providing technical support for multiple contract laboratories
Supporting the internal and external audit programme
Authoring of new procedures, review and approval of existing procedures
Maintain analytical equipment under GMP and contribute to equipment validation
Work independently with minimal supervisory guidance
QC Scientist Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QC Scientist
List any licenses or certifications required by the position: ASQ
Education for QC Scientist
Typically a job would require a certain level of education.
Employers hiring for the QC scientist job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Science, Biology, Biochemistry, Physical Science, Microbiology, Manufacturing, Engineering, Life Science, Life Sciences
Skills for QC Scientist
Desired skills for QC scientist include:
Qualitative and quantitative chemical
Microbiological analysis
GMP regulations in cGMP manufacturing environment
Characterization and transfer of pharmaceutical products
Quality and regulatory requirements in the pharmaceutical industry
Qualitative and quantitative chemical analysis
Regulatory requirements concerning analytical test methods
EMPOWER
Qualitative and quantitative microbiological Tests
Scientific principles for wide range of analytical techniques strongly
Desired experience for QC scientist includes:
Use scientific expertise to provide assistance for troubleshooting, laboratory investigations and problem resolution
Work independently with moderate supervisory guidance
Review assay, process, and equipment validation reports, , other technical documents for technical correctness and regulatory compliance
Perform bioassay development/validation for QC
Responsible for all raw material and reagent testing
Knowledgeable of company cGMPs industry regulations that apply to job functions
QC Scientist Examples
1
QC Scientist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a QC 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 QC scientist
- Manage resources to meet program objectives
- Review all equipment before use – check calibration status and ensure equipment is working properly
- Notify laboratory management of any non-conformances with regards to procedures, equipment calibration, test deviations
- Update laboratory management of status of assigned tasks – including completion, delays, problems
- Report hours spent on each project using Laboratory Request database
- Report test results/observations accurately and in a timely fashion
- Perform operational activities as assigned by laboratory management – ordering supplies, sample logging, inventory management
- Perform routine projects and testing with minimal supervision
- Review job request, relevant MSDS and fully understand requirements in accordance with laboratory SOPs
- Determine availability of required equipment and materials – prepare or order required materials
Qualifications for QC scientist
- Working knowledge with Next-Gen sequencing or Master's degree in related discipline
- Proficiency in Excel and Jump or Minitab
- Ability to perform independently & as part of a team
- Experience with the ION Torrent platform
- Experience in Pharma, Medical Device, or clinical lab QC environment
- Experience with ISO 13485 and cGMP
2
QC Scientist Job Description
Job Description Example
Our company is looking for a QC 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 QC scientist
- Document preparation appropriately using datasheets or laboratory notebooks Performing test in pilot plant scale
- Assemble test apparatus in pilot plant scale
- Correctly operate, understand and be able to troubleshoot all equipment/instrumentation necessary to support testing
- Perform test work according to laboratory request requirements
- Immediately notify laboratory management of any test delays, problems or deviations
- Test completion
- Disassemble and clean test equipment and work area
- Record any remaining test information
- Create an accurate and timely laboratory report reflective of the laboratory request requirements
- Report hours spent on project
Qualifications for QC scientist
- MS Office computer skills required for record and analysis reporting – Word, Excel
- To have detailed knowledge and be able to conduct Finished Product QC release testing as required by the role with daily supervision as required using techniques such as Balances, pH meter, UV, Karl Fisher, FT-IR, TLC, Dissolution, HPLC (to include degradation analysis), Coulometric Karl Fisher
- To be able to perform basic trouble shooting for all laboratory equipment
- To be able to generate a detailed test plan for a validation project, including the creation of an Analytical Summary Report
- To be able to write or check a stability report based on the protocol and test results generated
- Be able to complete entries for the receiving of product for testing on the product tracking sheets, including the understanding of testing timelines in conjunction with Customer Request Dates
3
QC Scientist Job Description
Job Description Example
Our company is growing rapidly and is hiring for a QC scientist. Please review the list of responsibilities and qualifications. While this is our ideal list, we will consider candidates that do not necessarily have all of the qualifications, but have sufficient experience and talent.
Responsibilities for QC scientist
- Responsibility for maintenance of such a system may be assigned
- Attend customer audits as required
- Adhere to Pall Corporate policies, local Quality Manual, local Health & Safety policies, general laboratory rules
- Provide technical support and leadership pertaining to analytical/microbiological testing
- Develop and maintain technical expertise
- Coordinate and direct the use of laboratory resources to meet manufacturing/packaging schedules, distribution and market requirements, stability commitments, and validation/process engineering initiatives
- Assess the training needs of the staff to coordinate training as necessary
- Release (approve/reject) QC data from the laboratory for purposes such as manufacturing, product release to the commercial market, and stability reporting
- Participate/assist in laboratory investigations for out of specification or atypical results
- Perform analytical testing and wet chemistry practices for bioassay/immunoassay in a GMP environment (ELISA, SPR, Interferometry, cell culture, general aseptic techniques, FACS, fluorescence/luminescence/optical detection)
Qualifications for QC scientist
- Influences and implements best practices wrt Lab methodology and procedures
- Be able to perform preliminary investigations of deviations, complete investigation forms and write basic deviation reports
- Identifies own training needs and performs training of other as required by line management
- Reporting of own results and the data verification other scientists results for QC Release, Stability and In-Process Validation as required by the role
- To ensure all analysis is conducted in accordance with company procedures
- Experience of working in Hazardous& complex environments
4
QC Scientist Job Description
Job Description Example
Our company is hiring for a QC scientist. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for QC scientist
- Understands test results and pursues clarification of unusual results
- Document preparation appropriately using datasheets or laboratory notebooks
- Performing test in pilot plant scale
- Receive assays from biochemistry development group and implement them in the QC laboratory
- Work with relevant subject matter experts from IOPS and Tarrytown laboratory management to determine best practices for biochemistry assay design and execution
- In relation to irradiation customers
- Researches, performs and documents validation support studies following defined procedures
- Performs analysis of finished products, validation samples, in-process materials and raw materials, moisture testing, Gas, Water and manufacturing environmental sampling and testing according to the effective protocols, Methods and Compendials
- Logs results in LIMS database
- Must be capable of writing and or revising Standard Operating Procedures and Test methods
Qualifications for QC scientist
- Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements
- Document all activities associated with cGMP / cGLP / cGDP compliance
- Perform statistical analysis of QC data
- Maintain accurate and up-to-date training records
- Any other duties as requested by the Company’s management
- Apprenticeship or BSc degree as food technician, chemistry technician, biotechnologist, process engineer or as lab assistant in the fields of biology or physics
5
QC Scientist Job Description
Job Description Example
Our innovative and growing company is searching for experienced candidates for the position of QC 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 QC scientist
- Helps develop new analytical methods or modifies current methods
- Able to participate in method transfers and assist with developing transfer protocols
- On an as needed basis, maintains proper documentation of Laboratory equipment
- May assist in providing guidance/training to new and existing personnel
- Fosters communication with group members and the supervisor
- Helps maintain and store supplies inventory
- Files and maintains laboratory records
- Must be able to provide training to new or existing personnel
- Required to calibrate, maintain and clean laboratory instruments and equipment
- Wash glassware used to perform chemical analysis if needed
Qualifications for QC scientist
- Good English and German language skills written and spoken
- Minimum MS degree
- Technical proficiency in biology, chemistry or related field
- Experience in quality control methods and applications such as test method validation and statistical analysis a plus
- Data analysis competency
- Able to schedule activities to meet time requirements and move multiple projects forward simultaneously without compromising quality