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Quality Assurance Specialist
Axelon Services Corporation
Gaithersburg, MD (Onsite)
Full-Time
Quality Assurance Specialist
Gaithersburg, MD
2 Months
Pay rate: $25/hr - $30/hr
•*Role is covering for a leave, possibility that the assignment can be extended.
•*Candidate will need to be on site full time, 5 days per week.
**Ideally would like someone who has experience with analytical testing or is hands on with analytical testing,
•*If they have quality experience supporting a lab would be helpful and reviewing deviations
Description:
Responsibilities:
" Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, method and technical reports, etc., that are submitted to QA for approval.
" Reviews technical documents such as method qualification/validation reports, technical transfer reports, regulatory filings, (specific to position as determined by manager)
" Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives. Must be able to utilize wide range of problem solving and risk management tools
" Complete understanding and wide application of technical principles, theories and concepts in the areas of clinical manufacture of biologics. To include process development methodology, analytical methods, technology transfer, and CMC Processes. plant and relational database automation, aseptic processing and CMC processes. Must have strong technical expertise in several of these areas. General knowledge of other related disciplines.
Education:
BS in Biology
Minimum 1 years of experience in Quality or QC.
Gaithersburg, MD
2 Months
Pay rate: $25/hr - $30/hr
•*Role is covering for a leave, possibility that the assignment can be extended.
•*Candidate will need to be on site full time, 5 days per week.
**Ideally would like someone who has experience with analytical testing or is hands on with analytical testing,
•*If they have quality experience supporting a lab would be helpful and reviewing deviations
Description:
Responsibilities:
" Reviews documents such as SOPs, deviations, change control requests, corrective and preventive action plans, validation protocols/reports, method and technical reports, etc., that are submitted to QA for approval.
" Reviews technical documents such as method qualification/validation reports, technical transfer reports, regulatory filings, (specific to position as determined by manager)
" Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives. Must be able to utilize wide range of problem solving and risk management tools
" Complete understanding and wide application of technical principles, theories and concepts in the areas of clinical manufacture of biologics. To include process development methodology, analytical methods, technology transfer, and CMC Processes. plant and relational database automation, aseptic processing and CMC processes. Must have strong technical expertise in several of these areas. General knowledge of other related disciplines.
Education:
BS in Biology
Minimum 1 years of experience in Quality or QC.
Recommended Skills
- Test Data
- Software Testing
- Test Automation
- Test Planning
- Hp Quality Centers
- Test Strategy
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