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Innova Solutions ยท 2 days ago
Quality Auditor - Scientific - II
Rahway, NJ
Full-time
Onsite
Entry Level
1+ years exp
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Responsibilities
Perform independent quality review and approval of batch records, testing data, and related documents required to release or reject product. Make independent batch release or reject decisions.
Conduct independent auditing, review, and approval of diverse and complex document types, including deviations, investigations, analytical method validations, method transfers, analytical methods, specifications, certificates of analysis, etc.
Collect, prepare and analyze data to support quality system metrics and planning.
Perform document management activities such as cataloging records for long term document storage according to retention policies.
Support compliance activities such as site readiness, audits, and CAPAs.
Support quality risk management activities.
Support projects for continuous quality improvement. Utilize project management skills as needed.
Provide meeting coordination, facilitation, scribing, and communication.
Develop, write, technical edit, or review procedures or other standards documents under GMP.
Other duties as assigned by manager for the flexible functioning of the work group.
Qualification
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Required
Bachelor degree (B.S.) in an appropriate Science or Engineering discipline (engineering, chemistry, biology, biochemistry, microbiology). Minimum of 1 year experience preferred. Recent graduate can be considered.
Experience in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
Knowledge of R&D or clinical supply areas and processes.
Experience in one or more functional areas such as quality control, quality assurance, laboratory, manufacturing, production, equipment/facilities management, regulatory.
Good Manufacturing Practice (GMP) or related drug regulation knowledge and expertise.
Strong leadership, collaboration, teamwork, negotiation, communication, and workload management skills.
Ability to work in a dynamic R&D environment with rapidly changing needs.
Demonstrated ability to manage projects, priorities, to meet deliverables and timelines.
Ability to work across functional and sites, with all levels of staff and management.
Qualified candidates should have proficiency with Microsoft Suite (Word, Excel, PowerPoint, Teams, etc.) and ability to adapt to learning other electronic systems to support day-to-day work.
Fully onsite during training period, transitioning to Hybrid role requiring 3 days onsite a week.
Local candidates preferred #J-18808-Ljbffr
Preferred
Preferred API knowledge and experience.
Company
Innova Solutions
Innova Solutions is an IT company that specializes in data analytics, cloud computing, cyber security, and machine learning.
10,001+ employees
H1B Sponsorship
Innova Solutions 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
Trends of Total Sponsorships
2023 (248)
2022 (74)
2021 (32)
2020 (79)
Funding
Current Stage
Late StageLeadership Team
Raj Sardana
Founder, Chairman and CEO
Company data provided by crunchbase
