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
Job Title: Quality Operations Specialist I
Primary Location: Princeton, NJ
Duration: 12+ Months (Extendable)
Pay Rate: $30-$33.97/hr on W2
Key Requirements:
• Experience: 1–3 years (minimum); no freshers
• Clinical ops, CRA, or Quality internships are acceptable
• Strong communication, attention to detail
• Must articulate skills clearly in interview
• Project management/admin skills helpful
• Role involves communication across business lines, pushing timelines forward
• Cannot be someone’s first job in pharma
Additional Context:
• Involvement with FDA, PADE, EUGCP inspections
• High visibility and opportunity to grow into quality
• No spotlight call unless hiring stalls
Manager is seeing someone with STRONG soft skills in good and proactive communication, who can communicate with multiple sectors of the business to politely push them forward and meet quality deadlines. It cannot be someone's first role in pharma or clinical operations, but does not need to have extensive experience as long as the detail oriented, project management, and communication proficiency is high.
Position Summary:
Responsible for assigned operational Quality Risk and Compliance (QRC) activities supporting Research and Development (R&D) quality efforts, including support of inspection readiness (IR), process improvement, quality metrics, and other assigned duties.
Candidate will be required to work closely with internal R&D teams across all departments such as Clinical Development, Clinical Operations, Biometrics, Regulatory Affairs, Drug Safety and Pharmacovigilance, Translational Sciences, Program Management, and Medical Affairs.
Primary Duties and Responsibilities:
• Inspection Readiness(IR) Support
o Tracking and closure of IR actions across multiple parallel workstreams, assist with meeting minutes, scheduling of meetings, trainings, etc.
o Manage updates to Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), Good Manufacturing Practices (GMP) SME Lists for Inspections
o Follow-up on mock inspection Corrective and Preventive Actions (CAPA) closure and completion of lessons learned
• Quality Metrics Support
o Follow-up with study teams on metrics responses
o Follow-up with teams with Spot Check responses due
o Follow-up on training due (based on PowerBI compliance metrics)
o Pull raw data from systems for metrics generation as requested
• Other Quality Operations Support
o Follow ups for process improvement program
o Budget/invoice tracking for QRC
o Tracking of new and revised controlled documents – follow ups with curricula owners on training changes, processing of Adobe Forms
o Scheduling of quality related training workshops
o Other internal meeting scheduling, minute taking, action item follow-ups as needed
o other duties as assigned/required.
Must possess:
• Excellent communication skills, both verbal and written.
• Able to work independently as well as in cross-functional teams.
• Excellent pro-active, interpersonal, problem-solving, conflict resolving skills.
• Flexibility to switch between projects and assignments; ability to manage multiple projects, work streams and activities on a daily basis.
• Able to gain cooperation of others.
• Proficient computer skills, including Microsoft Word, PowerPoint and Excel. Power BI experience a plus
Education/Experience/Skills:
Bachelor’s degree in Science or a related field. Targeting 1-3 years of progressively responsible experience within the pharmaceutical or biotech industry, including 1 year in Quality and/or Clinical Operations or other R&D function. An equivalent combination of relevant education and experience may be considered.
Regards,
Prateek Pampattiwar
Recruitment Specialist
Net2Source Inc.
Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA
Office: (201) 340-8700 x 324 | Cell: (551) 220 3007| Fax: (201) 221-8131| Email: Pampattiwar.Prateek@net2source.com
...position reports directly to the Logistics Manager for Minnesota/North Dakota/South Dakota. For more information text your name and Depot Manager to (***) ***-****. As a full-time employee, you can choose from a full menu of our Top Shelf Benefits, including...
...CDL A required Must be 21 or older No experience needed if you graduated from a CDL school New drivers welcome. Get paid to train, earn consistent miles, and start building your future with a stable carrier. Training and Orientation: Duration: 4 to...
...lead capital improvement projects. Must have a Bachelor's degree in Engineering. Preferred experience includes CNC programming, Lean/Six Sigma methodologies, and SAP; bilingual in Spanish is a plus. Strong problem-solving skills and the ability to collaborate across...
4:00AM-6:00PM M-F CDL Rear Load Drivers are responsible for servicing customers with the collection and hauling of waste or recycling... ...: Operate truck in a safe manner in compliance with all local, state, and federal regulations and company policies. Provide...
...Trainee, you will work closely with Department Management to learn each departments functions and how each department helps the Distribution Centers success. Menards, based out of Eau Claire, WI is a privately owned company and leader in the home improvement retail...