Deviation Investigator
Net2Source (N2S), Devens, MA, United States
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 Description:
Job Title: Deviation Investigator
Location: Devens, MA 01434 (50% Onsite)
Duration: 06 months(possibility of extension for right candidate depending on performance)
Pay Rate: $50.00 - 53.21/hr on W2
Must Haves:
Required Bachelor’s degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2–4 years of relevant experience (or equivalent).
Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
Major Duties and Responsibilities:
Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
Liaise with multiple groups and organizations to ensure effective collaboration.
Proactively manage the progression of investigations and CAPAs to achieve timely closure.
Lead and participate in cross-functional investigation teams.
Present investigation findings to key stakeholders and site management.
Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
Knowledge and Skills:
Required Bachelor’s degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2–4 years of relevant experience (or equivalent).
Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
Strong project management skills, including organization, collaboration, multi-tasking, and communication.
Attention to detail and ability to perform well in a team-based environment.
Excellent verbal and written communication skills, with the ability to present information clearly and concisely.
Strong interpersonal and collaboration skills to influence all levels of the organization.
Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred.
Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
Contacts
Work collaboratively with all departments and across all organizational levels.
Working Conditions
Assignments primarily occur in the Large-Scale Cell Culture building, Single-Use Facility, and Quality Control Laboratory areas, requiring strict adherence to Personal Protective Equipment (PPE) standards. Site is located in Devens, Massachusetts.
Decision-Making
Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges.
Supervision Received
Assignments generally follow defined processes but may require judgment and independent detail definition. Supervisory guidance is provided as needed, with oversight determined by the complexity and impact of the task.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for the 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)
Company: One of Our Clients
Job Description:
Job Title: Deviation Investigator
Location: Devens, MA 01434 (50% Onsite)
Duration: 06 months(possibility of extension for right candidate depending on performance)
Pay Rate: $50.00 - 53.21/hr on W2
Must Haves:
Required Bachelor’s degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2–4 years of relevant experience (or equivalent).
Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
Major Duties and Responsibilities:
Conduct and manage the resolution of deviations, root cause investigations, impact assessments, and CAPAs.
Liaise with multiple groups and organizations to ensure effective collaboration.
Proactively manage the progression of investigations and CAPAs to achieve timely closure.
Lead and participate in cross-functional investigation teams.
Present investigation findings to key stakeholders and site management.
Apply Quality Risk Management and Operational Excellence principles to enable risk-based decision-making, drive continuous improvement, and eliminate waste.
Investigate Quality Control deviations, including Out-of-Specification (OOS) and Out-of-Trend (OOT) results.
Knowledge and Skills:
Required Bachelor’s degree in chemical/biochemical engineering, biological sciences, or a related discipline with 2–4 years of relevant experience (or equivalent).
Prior experience leading cGMP investigations using formal Root Cause Analysis tools required.
Strong project management skills, including organization, collaboration, multi-tasking, and communication.
Attention to detail and ability to perform well in a team-based environment.
Excellent verbal and written communication skills, with the ability to present information clearly and concisely.
Strong interpersonal and collaboration skills to influence all levels of the organization.
Familiarity with SOPs, cGMPs, and working within a regulatory environment preferred.
Knowledge of cell culture, recovery, and/or purification biopharmaceutical manufacturing preferred.
Contacts
Work collaboratively with all departments and across all organizational levels.
Working Conditions
Assignments primarily occur in the Large-Scale Cell Culture building, Single-Use Facility, and Quality Control Laboratory areas, requiring strict adherence to Personal Protective Equipment (PPE) standards. Site is located in Devens, Massachusetts.
Decision-Making
Take action, make recommendations, and work with minimal supervision while collaborating with management to resolve challenges.
Supervision Received
Assignments generally follow defined processes but may require judgment and independent detail definition. Supervisory guidance is provided as needed, with oversight determined by the complexity and impact of the task.
Awards and Accolades:
America's Most Honored Businesses (Top 10%)
Awarded by USPAAC for the 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)