### Job_Dedcrip:
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 Description: Title: Quality Records Specialist Duration: 12 months with possible extension Location: Hybrid-Summit, NJ 07901  50 % onsite 50% remote  Pay: $25-29/hr on w2  PURPOSE AND SCOPE OF POSITION: The Global Supplier Quality, External QC -Vector will process external deviation and change records from our Contract Test Laboratories (CTL). Other duties may include; Coordinate shipping and testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a CoA/CoT. This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.   DUTIES AND RESPONSIBILITIES:  Initiation, facilitation, and tracking of quality records  Provide regular communication and metrics for status of quality records  Effectively communicate issues, risks and proposed solutions within the organization  Provide communication, support, and guidance to CTLs within the QA vector and upstream material team Other duties may include:  Working closely with other GSQ QC members to submit and track sample material for testing at CTL  Create and revise SOP  Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT)  Enter data and retrieve information from Sharepoint and Smartsheet testing trackers   Education and Experience: Required minimum Associates of Science degree in relevant scientific discipline, OR 3 years' experience in biotherapeutics/biomanufacturing QC/QA   REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:  Experience with deviation and change control management, preferably with Infinity systems  Strong organizational skills, including ability to follow assignments through to completion  Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams  Detail oriented with demonstrated application in problem solving With moderate oversight from manager, think strategically and understand global impact of decisions   DESIRED COMPETENCIES: Knowledge, Skills, and Abilities:  Advanced project management skills such as process excellence/six sigma methods and approaches including process mapping, root cause analysis and problem definition Experience within the Cellular Therapeutics and/or gene-based products. Experience with biologics will be considered. Experience with Clinical and/or Commercial products manufacture, supply and post-approval change management  Knowledge of applicable FDA/EMA regulations in the biotechnology industry Experience managing external suppliers and other supply chain issues Experience with Quality Systems (change control, deviation and investigation)   WORKING CONDITIONS (US Only):  May be required to work in office environment.  Sitting, standing and computer work is required.  Ability to participate in conference calls.  This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.  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)

### Response:

Job Requirements:- Required minimum Associates of Science degree in relevant scientific discipline, OR 3 years' experience in biotherapeutics/biomanufacturing QC/QA- Experience with deviation and change control management, preferably with Infinity systems- Strong organizational skills, including ability to follow assignments through to completion- Ability to work in a fast-paced environment, meet deadlines, and prioritize work from multiple projects- Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams- Detail-oriented with demonstrated application in problem-solving- Knowledge of applicable FDA/EMA regulations in the biotechnology industry- Experience managing external suppliers and other supply chain issues- Experience with Quality Systems (change control, deviation and investigation)