Role & seniority: Quality Assurance Engineer I (entry-to-mid level) with 3+ years in quality/regulatory within pharmaceutical environments.

Stack/tools: Regulatory submissions/CMC work; Veeva Vault (data entry); adherence to RA procedures, templates and schedules; familiarity with US FDA, EU, Canada standards.

Top 3 responsibilities

Authoring and reviewing CMC components for submissions (post-approval changes, annual reports, new licenses, renewals, responses) and coordinating final submissions.
Assessing change-control pre-requests/requests for Canada, US, Europe and preparing the global regulatory strategy.
Data entry in regulatory systems (Veeva Vault) and supporting internal requests (quality deviations, data checks, license info, lot-release questions).

Must-have skills

3+ years in quality/regulatory within pharma (preferably vaccines/biologics)
Experience with CMC submissions and regulatory strategy
Familiarity with US FDA, European, and Canadian standards
Proficiency in Veeva Vault or similar regulatory systems
Strong written/verbal communication and teamwork

Nice-to-haves

Vaccine/biologic experience
Ability to work independently in addition to team collaboration
Bachelor’s degree in science, engineering, or related field

Location & work type: Short Hills, NJ; 6-month contract (on-site).

Full Description

Hi,

Net2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring " Quality Assurance Engineer I" for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to Start-ups across various verticals like Technology, Financial Services, Healthcare, Life Sciences, Oil & Gas, Energy, Retail, Telecom, Utilities, Technology, Manufacturing, the Internet, and Engineering.

Company: One of Our Clients

Position: Quality Assurance Engineer I

Location: Short Hills, NJ

Duration: 6 months

Job Description

Required Experience and Skills

3+ years experience working within quality, regulatory and/or within pharmaceutical environment preferably in vaccines or biologic experience, is required
Authoring and reviewing of CMC components for various submissions (e.g., post-approval changes, US annual reports, new license applications, renewals, commitments, response to questions) within pre-defined schedules in accordance with RA procedures, tools and templates and coordinating the final submissions, if required
Candidate to be familiar with the main regulatory agency standards (US FDA, Europe and Canada)
Assessing change control pre-requests and requests for Canada, US and Europe and preparing the global regulatory strategy
Completing data entry for various activities in the regulatory system (i.e., Veeva Vault)
Supporting various internal request (e.g., Quality deviations and assessments, data checking, license information, lot release questions, etc.)
Ability to work in a group setting and independently; good teamwork skills
Strong interpersonal and communication skills, both verbal and written

Comments for Suppliers

Education

Bachelor's degree in science, engineering, or related areas of study.

About Net2Source, Inc. Net2Source is a total talent management solutions company with its presence in 50+ countries. Our creative solution service offerings aim at becoming your one stop destination for hiring talent needs globally. Want to read more about Net2Source? Visit us at www.net2source.com

Equal Employment Opportunity Commission The United States Government does not discriminate in employment on the basis of race, color, religion, sex (including pregnancy and gender identity), national origin, political affiliation, sexual orientation, marital status, disability, genetic information, age, membership in an employee organization, retaliation, parental status, military service, or other non-merit factor.

Net2Source Inc. is one of the fastest growing Global Workforce Solutions company with a growth of 100% YoY for last consecutive 3 years with over 4100+ employees globally and 30+ locations in US and operations in 50+ countries. With an experience of over a decade we offer unmatched workforce solutions to our clients by developing an in-depth understanding of their business needs. We specialize in Contingent hiring, Direct Hires, Statement of Work, Payroll Management, IC Compliance, VMS, RPO and Managed IT Services.

Fast Facts about Net2Source

Founded in 2007
100% Minority Owned, Debt Free, Private
4100+ consultants globally
2550 consultants placed in the US
750+ team of in-house staffing team
30+ sales offices in the US, and 50+ Offices globally
Operations in 20 countries (US, Canada, Mexico, APAC, UK, UAE, Europe, , Europe, Latin America, Japan, Australia)

Awards and Accolades

2020 Fast 100 Asian American Businesses by the US Pan Asian American Chamber of Commerce Education Foundation (USPAACC 2019)
2019 & 2018 Ranked 21st Fastest Growing Staffing Company in USA by Staffing industry Analysts
2019 & 2018 Fastest 50 by NJ Biz (Ranked (9th and 27th ).
2019 Top 100 Fastest companies to grow in Dallas by Dallas Business Journal.
INC 5000 Fastest growing for 8 consecutive years in a row.
America's Most Honored Businesses (Top 10%)
2019 Dallas Top 100 by Dallas Business Journal
2019 Proven Supplier of the Year by Workforce Logiq
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)

Thanks

Regards, Swati Rai Sr. Technical Recruiter Net2Source Inc.

Global HQ Address: 7250 Dallas Pkwy, Suite 825 Plano, Texas 75024

Office: (201) 340-8700 x 547 | Cell: (201) 623-3468 Email Id: swati.rai@net2source.com

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