Quality - Assistant QC Scientist - Net2Source
Warren, NJ 07059
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: Assistant QC Scientist
Duration: 12 months contract (Possible Extension)
Location: Warren, NJ 07059
Pay Rate Range: $ 39.27 - 41.93/hr on W2.
Onsite role at Warren NJ
Work Schedule: Mon - Fri, 8AM - 4:30PM EST
Must Haves:
2+ years of hands-on experience with bioanalytical technique such as ELISA, Potency, Cell based assays, etc.
1+ Experience working in regulated environment (e.g. cGMP, cGLP)
Previous Assay Transfer, assay validation experience
Previous CAR-T experience preferred
Technical understanding and troubleshooting skills
Experience/knowledge in deviation, CAPA, Change Control
Team player, flexible, good communication skills
Purpose:
The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
Required Competencies: Knowledge, Skills, and Abilities
• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based
assays.
• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Technical writing skills.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to set priorities of the group and manage timelines.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.
Duties and Responsibilities
• Perform testing of in-process, final product, stability samples, and method transfer.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• Understanding of regulatory guidelines.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
• Document training per procedural and cGMP requirements.
• Perform assigned tasks within a CAPA, deviation, or project
• Draft and review technical documents, such as SOPs and forms.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Performs other tasks as assigned.
Education and Experience
• Bachelor’s degree required, preferably in Science.
• 2-3 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but less exp. (1-2 years), manager would still consider that candidate.
Working Conditions
• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is
required.
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting up to six (6) hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.
Additional Information:
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
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:
Lab w/o blood & animal
Position Handles Hazardous Materials
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)
Job Title: Assistant QC Scientist
Duration: 12 months contract (Possible Extension)
Location: Warren, NJ 07059
Pay Rate Range: $ 39.27 - 41.93/hr on W2.
Onsite role at Warren NJ
Work Schedule: Mon - Fri, 8AM - 4:30PM EST
Must Haves:
2+ years of hands-on experience with bioanalytical technique such as ELISA, Potency, Cell based assays, etc.
1+ Experience working in regulated environment (e.g. cGMP, cGLP)
Previous Assay Transfer, assay validation experience
Previous CAR-T experience preferred
Technical understanding and troubleshooting skills
Experience/knowledge in deviation, CAPA, Change Control
Team player, flexible, good communication skills
Purpose:
The QC Analyst is responsible for supporting Quality Control bioanalytical testing for release of clinical and commercial products. This includes the ability to interface with multiple groups, the ability to independently perform tasks, interpret results, and troubleshoot. Additionally, when needed, this position will be able to assist with training and assay transfer.
Required Competencies: Knowledge, Skills, and Abilities
• Hands-on experience with various bioanalytical techniques including ELISA, qPCR and FACS and cell-based
assays.
• Experience in assay transfer, technology transfer, validation from Analytical Developmental group to Quality Control group.
• Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements.
• Technical writing skills.
• Problem-solving ability/mentality, technically adept and logical.
• Ability to represent the interests of the group on cross-functional teams.
• Ability to set priorities of the group and manage timelines.
• Ability to work with management locally and globally.
• Ability to communicate effectively with peers, department management and cross-functional peers.
Duties and Responsibilities
• Perform testing of in-process, final product, stability samples, and method transfer.
• Utilize scientific principles to assist in analytical testing methods and the proper use of laboratory equipment.
• Anticipate and troubleshoot problems.
• Recommend corrective actions and participate in the development of best practices.
• Understanding of regulatory guidelines.
• Complete all work in a timely manner.
• Work and communicate effectively within the team to ensure timelines are met.
• Apply technical knowledge and abilities to ensure all testing is performed in a compliant manner.
• Communicate effectively with peers, and demonstrate teamwork, with regards to results of review and corrections required.
• Document training per procedural and cGMP requirements.
• Perform assigned tasks within a CAPA, deviation, or project
• Draft and review technical documents, such as SOPs and forms.
• Communicate effectively with management regarding task completion, roadblocks, and needs.
• Performs other tasks as assigned.
Education and Experience
• Bachelor’s degree required, preferably in Science.
• 2-3 years of relevant work experience, preferably in a regulated environment.
• An equivalent combination of education and experience may substitute. EX: if the person has a Master degree but less exp. (1-2 years), manager would still consider that candidate.
Working Conditions
• The incumbent should be able to distinguish colors and possess correctable vision to 20/20, annual eye exam is
required.
• The incumbent must analyze numerical values on a daily basis.
• The incumbent will be working a laboratory setting up to six (6) hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, up to six (6) hours per day.
Additional Information:
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
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:
Lab w/o blood & animal
Position Handles Hazardous Materials
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)
Source : Net2Source