What are the responsibilities and job description for the CHEMISTRY 7 - ASSOCIATE SCIENTIST � QC SAMPLE MANAGEMENT position at Net2Source Inc.?
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 Description: Schedule - Monday-Friday; Standard Business Hours
100% Onsite Position!
The Assistant Scientist, Clinical QC Sample Management position is responsible for the movement and control of Quality Control (QC) samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Warren, NJ. This primarily includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, documentation, and shipments within the cGMP operation for CTDO Developmental QC for CAR T.
Required Competencies: Knowledge, Skills, and Abilities
" Experience with cold chain sample storage and transfer.
" Experience working in a GMP regulated environment.
" Strong communication skills (oral and written). Proficient with computer software programs/ applications and capable of preparing technical reports as required.
" Ability to follow and apply global regulatory and GMP requirements.
" Ability to follow, create, revise, and review SOPs.
" Ability to work in a collaborative team environment.
" Ability to work independently for extended periods of time with minimal supervision.
" Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Duties and Responsibilities
" Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: receipt, handling, storage, distribution, transfer, and destruction of QC samples at the site.
" Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
" Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
" Performing sample queries and periodic storage reports, as required.
" Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
" Initiating and performing investigations, Deviations/CAPAs/Change Controls related to sample management.
" Prepares and presents continuous improvement projects to management.
" Performs document review related to sample management.
" Create and revise SOP, FORM, WP, and TRN related to sample management.
" Provide range of support of QC services such as ordering and receipt of lab supplies.
" Establish and maintain inventory of QC incoming material, QC material retain, QC samples and QC regulatory retains.
" Coordinate and lead trainings for sample management.
" Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
" Assist in analytical sample trouble shooting and investigations as needed.
" Demonstrate general understanding of root cause analysis and CAPA methodologies.
" Maintaining metrics for the sample management group.
" Facilitating cold chain transfers of samples, as required.
" Assist with preparation and execution of equipment installations related to sample management.
" Perform other tasks as assigned.
Education and Experience
" Bachelors degree required, preferably in chemistry, microbiology, or related science.
" 2-3 years of relevant work experience, preferably in a GMP regulated environment.
" An equivalent combination of education and experience may substitute.
" Sample management experience is a PLUS.
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
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 inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith 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
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
Job Description: Schedule - Monday-Friday; Standard Business Hours
100% Onsite Position!
The Assistant Scientist, Clinical QC Sample Management position is responsible for the movement and control of Quality Control (QC) samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Warren, NJ. This primarily includes, but is not limited to, sample collection and distribution, inventory control, chain of custody, sample tracking, documentation, and shipments within the cGMP operation for CTDO Developmental QC for CAR T.
Required Competencies: Knowledge, Skills, and Abilities
" Experience with cold chain sample storage and transfer.
" Experience working in a GMP regulated environment.
" Strong communication skills (oral and written). Proficient with computer software programs/ applications and capable of preparing technical reports as required.
" Ability to follow and apply global regulatory and GMP requirements.
" Ability to follow, create, revise, and review SOPs.
" Ability to work in a collaborative team environment.
" Ability to work independently for extended periods of time with minimal supervision.
" Ability to adapt and adjust to changing priorities and to manage multiple assignments with challenging/conflicting deadlines.
Duties and Responsibilities
" Ensures the chain of custody of QC samples are maintained throughout the complete life span of samples: receipt, handling, storage, distribution, transfer, and destruction of QC samples at the site.
" Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
" Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
" Performing sample queries and periodic storage reports, as required.
" Responsible for sampling clinical QC incoming materials in collaboration with warehouse personnel and CAR T QC incoming material team.
" Initiating and performing investigations, Deviations/CAPAs/Change Controls related to sample management.
" Prepares and presents continuous improvement projects to management.
" Performs document review related to sample management.
" Create and revise SOP, FORM, WP, and TRN related to sample management.
" Provide range of support of QC services such as ordering and receipt of lab supplies.
" Establish and maintain inventory of QC incoming material, QC material retain, QC samples and QC regulatory retains.
" Coordinate and lead trainings for sample management.
" Develop understanding and assembly of weekly process schedule assignment for drug product samples and incoming QC materials.
" Assist in analytical sample trouble shooting and investigations as needed.
" Demonstrate general understanding of root cause analysis and CAPA methodologies.
" Maintaining metrics for the sample management group.
" Facilitating cold chain transfers of samples, as required.
" Assist with preparation and execution of equipment installations related to sample management.
" Perform other tasks as assigned.
Education and Experience
" Bachelors degree required, preferably in chemistry, microbiology, or related science.
" 2-3 years of relevant work experience, preferably in a GMP regulated environment.
" An equivalent combination of education and experience may substitute.
" Sample management experience is a PLUS.
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
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 inwith an inclusive culture, focus on work-life fit and well-being, and a supportive, connected environment; but we also want you to stand outwith 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
Recruiter name
Designation
Office: (201) 340-8700 x XXX | Cell: (201) xxx xxxx | Fax: (201) 221-8131| Email:
