Quality Specialist - I

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 title: Quality Specialist - I
Location: West Point PA 
Duration: 06 months
Pay rate $39.92/hr on w2
Candidate is expected to work in a team atmosphere in collaboration with Supervisors, Process Engineers, and Equipment Maintenance Engineers. The selected person will support projects/programs and collaboratively resolve problems and issues through excellent communication, proactive planning, and project management skills.
The select person will independently perform a range of activities including, but not limited to:
• Execute classified facility, utility, and aseptic processing area EM(Environmental Monitoring) Program requirements.
• Manage change that supports improvement to the Environmental Monitoring program and area sterility assurance.
• Support investigation of Environmental Monitoring events.
• Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, Process Simulation support, etc.)
• Manage/maintain department EM metrics. Provide detailed analysis of metrics to SLP management for development of action plans.
• Use LIMS to plan Environmental Monitoring sampling tasks. Create and/or maintain Environmental Monitoring schedules, sampling locations, and area sampling maps.
• Create, update, review, and/or approval Standard Operating Procedures.
• Conduct routine Environmental Monitoring tasks, including but not limited to troubleshooting tester questions, making decision on Environmental Monitoring data review, planning facility requalification sampling, and ensuring routine reports are completed on schedule.
• Support Utilities Environmental Monitoring requirements, including clean gas and water sampling data trending.
• Review facility HEPA filtered air velocity documentation.
• Actively working in a multi-discipline cross functional project team environment
Quals--
• Bachelor's degree in Microbiology, Biological Sciences or Chemical Sciences/Engineering with minimum of 2 years relevant experience, or a Master's degree with 1 year of relevant experience.
Required Experience:
• Previous experience in an EM(Environmental Monitoring) role supporting sterile, biologic, or vaccine operations, and/or process development activities.
• Previous experience in aseptic unit operations.
• Previous experience in a regulated environment or knowledge of cGMPs.
• A good understanding of the regulatory guidelines governing GMP and sterile manufacturing is important.
Software:
• GLIMS
• MEDS system for Document repository
• Experience with MS office suite.
Note: M-F, onsite role at West Point, PA. Flexible shift start time (anywhere from 7am-9am EST).
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 in—with an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand out—with 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)
Regards
Smita Kumari
Delivery Manager
Office: (951-643-830 | Fax: (201) 221-8131| Email: smita@net2source.com