Quality - QA lead technical operations

Company: Net2Source
Location: Summit
Posted on: March 20, 2023

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.

Title:QA lead technical operations
Duration: 12 months
Location: Summit, NJ

Pay: $55/hr on w2

Job Description:
Responsibilities:
This position is responsible for providing support for Product Quality Complaint (PQC) investigations, Change Control, and other Quality Systems. This position will be responsible for operating cross-functionally, collecting necessary data and information associated with a number of Quality Systems. This position will facilitate and provide administrative support for meetings related to root cause analysis sessions with site SME's, Community of Practices/Network, Quality Systems team/department.

Primary responsibilities include:
Author, review, and approves Product Quality Compliant (PQC) investigations.
Ensure proper intake, initiation, evaluation, and investigation of PQC(s), provides input to functional groups during evaluation, investigation, closure and implementation of associated CAPA's
Contributes to the development and continuous improvement of the PQC process across the Cell Therapy Operations
Collaborate with cross functional teams (i.e. Scheduling & Cell Logistics , Global Drug Safety, manufacturing sites, etc.) to ensure proper communication and collaboration for PQC(s).
Support and train cross functional groups with guidance on PQC process to ensure accurate reporting, investigation, root cause analysis and corrective actions.
Perform routine and ad hoc Quality Systems metric reporting and analysis for the PQC(s) data.
Prepare metrics and perform periodic trend analysis for PQC(s) in support of CTDO management review.
Provide communication as to the status of PQC(s) deliverables to management, and stakeholders.
Act as PQC Subject Matter Expert (SME) to support cross functional groups for PQC(s) intake, investigations, approval, and reporting.
Support internal, external audits and regulatory inspections such as data gathering, PQC process support and/or other audit support functions as necessary.
Support corporate requests for compliance and regulatory assessments.
Support other Quality System administration as required.

Qualifications:
2+ year's relevant industry experience in a cGMP/FDA regulated environment, preferably 2 years Quality experience with one or more years of experience within Quality Systems.
Knowledge of science generally attained through studies resulting in a B.S. in Science, Engineering, Biochemistry or related discipline or its equivalent is preferred.
Knowledge of US and EU cGMP regulations and guidance.
Past experience where one was required to work in a team based environment with a diverse group of people.
Excellent writing and oral communication skills are required.

Additional Job Requirements:
None

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)

Keywords: Net2Source, New York , Quality - QA lead technical operations, IT / Software / Systems , Summit, New York