Global Product Development and Supply - Field Specialist QA Operations - Net2Source
Devens, MA 01434
About the Job
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: Field QA Operations Specialist
Location: Devens, MA 01434 - 100% onsite
Duration: 12 months (possible extension)
Work Schedule : Monday to Friday, 7AM - 3:30PM
Holidays included as the needs of the business warrant.
Pay Range: $50 - $56/hr on w2
JOB SUMMARY
The client is seeking a Contractor Field QA Specialist for the QA Operations organization at the SUF in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the SUF in accordance with client's policies, standards, procedures, and Global cGMP
JOB RESPONSIBILITIES
• Perform QA on the floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
EDUCATION REQUIREMENTS
• Relevant college or university degree required.
• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
QUALIFICATIONS REQUIRED
• Equivalent combination of education and experience acceptable.
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
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)
#INDLS
Job Title: Field QA Operations Specialist
Location: Devens, MA 01434 - 100% onsite
Duration: 12 months (possible extension)
Work Schedule : Monday to Friday, 7AM - 3:30PM
Holidays included as the needs of the business warrant.
Pay Range: $50 - $56/hr on w2
JOB SUMMARY
The client is seeking a Contractor Field QA Specialist for the QA Operations organization at the SUF in Devens, MA. The Contractor Field QA Specialist is responsible for quality activities for the SUF in accordance with client's policies, standards, procedures, and Global cGMP
JOB RESPONSIBILITIES
• Perform QA on the floor activities.
• Ensure manufacturing compliance with applicable procedures and batch records.
• Perform real time review of manufacturing batch records.
• Review manufacturing shop floor documentation.
EDUCATION REQUIREMENTS
• Relevant college or university degree required.
• Minimum 4 years relevant work experience, with experience in a Quality Assurance role.
QUALIFICATIONS REQUIRED
• Equivalent combination of education and experience acceptable.
• Must be action-oriented and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Must have sound knowledge and experience in FDA regulated cGMP warehousing, Quality, and compliance environments. Prefer to also have knowledge of GMP Manufacturing operations and processes.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues.
• Able to recognize conflict and notify management with proposed recommendations for resolution.
• Must possess an independent mindset. Work is self-directed.
• Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.
• Confident in making decisions for non-routine issues.
• Develops and revises procedures.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements. Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
• Able to effectively multi-task.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, change control, product complaints, deviations, investigations, and CAPA management.
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)
#INDLS
Source : Net2Source