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Senior Specialist Quality Assurance - Level II (Associate)

Company: Net2Source
Location: Jersey City
Posted on: June 4, 2021

Job Description:

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.

Company: One of Our Clients

Position: Senior Specialist Quality Assurance - Level II (Associate)

Location: Remote

Duration: 06+Months Contract

Job Description:

Required Skills: Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements. Must be able to handle multiple priorities at a time and immediately address urgent issues. Solves complex problems; takes a new perspective using existing solutions. Works independently, receives minimal guidance. Experience with administration and data entry of technical reports into internal databases. Explains difficult issues and works to build alignment around a complex situation. Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills. Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Track Wise Change Control (GCM). Accountable for medium sized projects with minimal resource requirements, risk and/or complexity. May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others. Strong knowledge of External Manufacturing management, supply chain, and operations. Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME) Communicates easily in English both verbally and in writing. Lean Six Sigma Systems training an advantage. Fluent in English language (reading, writing and speaking) Primary Activities may include, but are not limited to the following: Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations. Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer. Support routine and complex change requests and support process modification change controls. Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements. Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed. Gather, interpret and report, in a timely manner data for internal Annual Product Review (when required). Participate with site visits to build relationships and monitor efforts to improve the external manufacturers quality and reliability through ongoing oversight and formal communication programs and forums.


This is a Remote position always Background: Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) Previous experience within the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control. Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes. Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills. Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.

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 inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith 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)


Recruiter name: Amrit Agrawal

Designation: Delivery Manager

Office: (201) 340-8700 x 913 | Cell: (201) 416-6962 | Fax: (201) 221-8131| Email:

Keywords: Net2Source, Jersey City , Senior Specialist Quality Assurance - Level II (Associate), Other , Jersey City, New Jersey

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