Collabera · 21 hours ago
QA Specialist II
Collabera is seeking a QA Specialist II responsible for bioanalytical quality assurance testing within the Starlims and SAP system. The role involves maintaining the quality system, conducting quality testing, and supporting process improvements in a laboratory environment.
Responsibilities
Responsible for implementing and maintaining the effectiveness of the Quality system
Complete Quality testing as appropriate for products per procedures and review all data to determine conformance with specifications. Work in a high-paced laboratory environment and has multiple certifications
Experience with the following is a bioanalytical techniques are a hard requirement: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods
CAPA - Investigates standard testing out of tolerance and out of specification results including complaints. Supports ticket trending process and maintains quality records
Communications - Communicate and collaborate effectively within the team and management
Documentation - Maintain accurate and complete documents and records
Manage Product and Process Improvements - Participate in project and process improvement activities. Monitor performance of testing processes, implement process improvements, and foster a culture of continuous improvement
Supports work area processes and product development/improvement projects. Provide quality support to key processes and product development/improvement projects. Takes a lead in the lab to ensure Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) are executed and the lab is running efficiently
Management of Computer Systems - Maintain and update relevant computer applications
Quality/Compliance -Support manufacturing and testing operations as required, adhering to GMPs and GLPs. Possess a basic understanding of the Quality System; including the subsystems and is familiar with the Quality System Key processes. Keep abreast of the standards that regulate our industry. Participate and take all training and reviews as required on ISOtrain Learning Management System
Share Quality Knowledge - Shares quality knowledge, liaising with colleagues within team
Training - Undertakes all training and reviews as required
Sample & File Storage - Ensures storage of samples and documents in the appropriate filling systems
Lab Safety - Participates in lab safety
Qualification
Required
Bachelor's in a science or closely related discipline with 3-4 years' experience
Experience with bioanalytical techniques: HPLC, SDS-PAGE, Western Blot, Dot Blot, ELISA, Mass Spectrometry (MS), and microtiter plate methods
Demonstrate excellent communication (written and verbal) skills
Knowledge of manufacturing/testing of diagnostic products, diagnostic methods and applications
Excellent troubleshooting skills
Product/process improvement experience
Stability testing experience
Validations experience
Technical troubleshooting experience
Compliance knowledge
Internal and external audits knowledge
Knowledge of performance metrics
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Days/hours of paid sick and safe time
Days/hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Any additional benefits applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Recent News
2024-04-09
2023-01-20
2022-04-19
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