CSV Engineer / Software Quality
- Contractor
- Full-Time
- Hopkinton, MA
- Splintpharma
- Prefferd visa: OPT, CPT, F1, H4, Have H1 Visa, Need H1 Visa, EAD
- Posted 2 years ago – Accepting applications
-
Offerd Salary $ 25 - $ 45
-
Required Position 2-4 hires
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Experience 0-3 Years Required
Job Opening for CSV Engineer / Software Quality – Hopkinton, MA 9+ mos (Hybrid role by mostly onsite)
We currently working on below mentioned job opening i.,e. Job Opening for CSV Engineer / Software Quality – Hopkinton, MA 9+ mos (Hybrid role by mostly onsite). Please let me know if you are interested in applying for the same.
Quality Systems - Software QA is responsible for supporting QA review of software development lifecycle documentation with a specific focus on validation/implementation of new software systems.
Responsibilities Include:
Review/Approve Test Scripts
Review Validation Summary Reports, Installation Qualification, Operational Qualification, Performance Qualification, and Trace Matrices, escalate issue to management
Support the development of training content
Direct reports
This position will not have direct reports
5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
Ability to work independently to meet objectives and timelines
Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
Prior experience with electronic test systems preferred (e.g., Valgenesis, Kneat)
This is a full-time position (Monday through Friday) with some opportunity for remote work. Prefer 80% onsite (so 4 days per week, most likely)
Job Opening for CSV Engineer / Software Quality – Hopkinton, MA 9+ mos (Hybrid role by mostly onsite)
We currently working on below mentioned job opening i.,e. Job Opening for CSV Engineer / Software Quality – Hopkinton, MA 9+ mos (Hybrid role by mostly onsite). Please let me know if you are interested in applying for the same.
Quality Systems - Software QA is responsible for supporting QA review of software development lifecycle documentation with a specific focus on validation/implementation of new software systems.
Responsibilities Include:
Review/Approve Test Scripts
Review Validation Summary Reports, Installation Qualification, Operational Qualification, Performance Qualification, and Trace Matrices, escalate issue to management
Support the development of training content
Direct reports
This position will not have direct reports
5+ years relevant Quality Assurance experience in a pharma/biotech company, working within a regulated GMP environment.
Prior experience with implementing software systems and/or continuous improvement initiatives focused on software systems
Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
Ability to work independently to meet objectives and timelines
Has an awareness of cGMP and ICH regulations/ guidelines and GAMP-5
Prior experience with electronic test systems preferred (e.g., Valgenesis, Kneat)
This is a full-time position (Monday through Friday) with some opportunity for remote work. Prefer 80% onsite (so 4 days per week, most likely)