Quality Auditor - Scientific - Ii

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap - Right Talent - Right Time - Right Place - Right Price and acting as a Career Coach to our consultants.
Job title: Quality Auditor - Scientific - II
Location: Rahway NJ
Duration: 12 months
Pay rate $26.21/hr on w2
The GDQ Ops - API organization provides Quality oversight for manufacturing, testing, and release activities associated with clinical-stage API. We provide Quality oversight of product development activities integrated with operations and functional partners, while ensuring continuous GMP-compliant clinical supply for internally and externally manufactured API.
Under the direction of GDQ-Ops Supervision, the Contractor will be responsible for providing quality assurance oversight, performing diverse tasks, and participating in quality related projects. Responsibilities include the following activities: product release, quality system, compliance, document management, and any related activities needed under current Good Manufacturing Practice (cGMP). Ensure compliance with applicable GMP regulations, ICH guidelines, *** policies, and procedures.
The Contractor will support tasks that may include but are not limited to:
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, as required, 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.
Quals--
Skills:
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 should be in the pharmaceutical, biotechnology, chemical, medical device, or closely related industry.
Knowledge of R&D or clinical supply areas and processes.
Preferred API knowledge and experience.
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
Why work with us - At Net2Source, we believe everyone has an opportunity to lead. We see the importance of your perspective and your ability to create value. We want you to fit in-with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out-with opportunities to have a strategic impact, innovate, and take necessary steps to make your mark. We help clients with new skilling, talent strategy, leadership development, employee experience, transformational change management and beyond.
Equal Employment Opportunity Statement:
Net2Source is an Equal Opportunity Employer. We believe that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion or sexual orientation. Our rich diversity makes us more innovative, more competitive, and more creative, which helps us better serve our clients and our communities. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for Fastest Growing Business in the US
12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
Fastest 50 by NJ Biz (2020, 2019, 2020)
INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
Top 100 by Dallas Business Journal (2020 and 2019)
Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
2019 Spirit of Alliance Award by Agile1
2018 Best of the Best Platinum Award by Agile1
2018 TechServe Alliance Excellence Awards Winner
2017 Best of the Best Gold Award by Agile1(Act1 Group)
Regards
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email: