Associate Scientist
Spectraforce
Thousand Oaks, California
2 months ago
Job Description
Job Title :Associate Scientist
Duration:06 Months
Duration:8 AM - 5 PM PT,
location: Thousand Oaks, CA 91320
Description:
As part of the Translational Safety & Bioanalytical Sciences organization (TS&BA), this vital role is responsible for the quality control (QC) of nonclinical reports generated by the scientific staff in TS&BA and the Pharmacokinetic and Drug Metabolism (PKDM) groups.
This role will provide oversight of nonclinical report QC, contribute to data integrity review of electronic lab notebooks (ELN) and assure compliance with operational procedures.
Responsibilities include working across functional departments to support TS&BA and PKDM staff to assure data integrity of regulatory documents against study reports, study reports (nonGLP and GLP) against ELNs or other source data.
The candidate would benefit from prior experience in a nonclinical drug safety or pharmacokinetic lab environment and requires the ability to work in a dynamic team-based culture.
This position reports to a Principal Scientist in TS&BA.
Role Responsibilities:
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $26.00/hr.
Duration:06 Months
Duration:8 AM - 5 PM PT,
location: Thousand Oaks, CA 91320
Description:
As part of the Translational Safety & Bioanalytical Sciences organization (TS&BA), this vital role is responsible for the quality control (QC) of nonclinical reports generated by the scientific staff in TS&BA and the Pharmacokinetic and Drug Metabolism (PKDM) groups.
This role will provide oversight of nonclinical report QC, contribute to data integrity review of electronic lab notebooks (ELN) and assure compliance with operational procedures.
Responsibilities include working across functional departments to support TS&BA and PKDM staff to assure data integrity of regulatory documents against study reports, study reports (nonGLP and GLP) against ELNs or other source data.
The candidate would benefit from prior experience in a nonclinical drug safety or pharmacokinetic lab environment and requires the ability to work in a dynamic team-based culture.
This position reports to a Principal Scientist in TS&BA.
Role Responsibilities:
- Confirm the accuracy of experimental data contained in written reports against final summary analysis files and ELN, e.g., QC of text, tables and figures.
- Confirm that experimental data used in reports to support conclusions accurately reflect ELN data sources (traceability to various internal data repositories or systems or source data verification)
- Coordinate, organize and support the QC process by accessing multiple internal databases (e.g., ELN, CDOCs, RIM, LIMS, etc.) to complete the QC task.
- Confirm presence of supporting data files (raw and analyzed) in approved storage locations
- Confirm report formatting requirements are followed (i.e. table/figure titles and descriptions), including proofreading.
- Own the QC review of reports for different types of toxicology and pharmacokinetic nonclinical (non-GLP) study types to support IND-filings with a focus on ensuring data quality and integrity.
- Ability to aid in report formatting including regulatory filing requirements
- Master’s degree and/or 1+ years of related laboratory support experience, OR
- Bachelor’s degree and/or 2+ years of related laboratory support experience, OR
- Associate degree and/or 4+ years of related laboratory support experience, OR
- High school diploma or GED and 6 years of related laboratory support experience
- Complete understanding of technical principles and concepts to perform a wide range of work in a role.
- Ability to solve complex technical problems and work independently in a fast-paced environment.
- Effective verbal and written communication and interpersonal skills.
- Attention to detail.
- Knowledge of MS Office tools, such as Word, Excel, PowerPoint, Visio, and Outlook• Knowledge of regulatory (GLP and GCP) and pharmaceutical processes is recommended.
About Us: Established in 2004, SPECTRAFORCE® is one of the largest and fastest-growing diversity-owned staffing firms in the US. The growth of our company is a direct result of our global client service delivery model that is powered by our state-of-the-art A.I. proprietary talent acquisition platform, robust ISO 9001:2015/ISO 27001 certified processes, and strong and passionate client engaged teams. We have built our business by providing talent and project-based solutions, including Contingent, Permanent, and Statement of Work (SOW) services to over 140 clients in the US, Canada, Puerto Rico, Costa Rica, and India. Key industries that we service include Technology, Financial Services, Life Sciences, Healthcare, Telecom, Retail, Utilities and Transportation. SPECTRAFORCE is built on a concept of “human connection,” defined by our branding attitude of NEWJOBPHORIA®, which is the excitement of bringing joy and freedom to the work lifestyle so our people and clients can reach their highest potential. Learn more at: http://www.spectraforce.com
Benefits: SPECTRAFORCE offers ACA compliant health benefits as well as dental, vision, accident, critical illness, voluntary life, and hospital indemnity insurances to eligible employees. Additional benefits offered to eligible employees include commuter benefits, 401K plan with matching, and a referral bonus program. SPECTRAFORCE provides unpaid leave as well as paid sick leave when required by law.
Equal Opportunity Employer: SPECTRAFORCE is an equal opportunity employer and does not discriminate against any employee or applicant for employment because of race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability or veteran status, or any other category protected by applicable federal, state, or local laws. Please contact Human Resources at LOA@spectraforce.com if you require reasonable accommodation.
California Applicant Notice: SPECTRAFORCE is committed to complying with the California Privacy Rights Act (“CPRA”) effective January 1, 2023; and all data privacy laws in the jurisdictions in which it recruits and hires employees. A Notice to California Job Applicants Regarding the Collection of Personal Information can be located on our website. Applicants with disabilities may access this notice in an alternative format by contacting NAHR@spectraforce.com.
LA County, CA Applicant Notice: If you are selected for this position with SPECTRAFORCE, your offer is contingent upon the satisfactory completion of several requirements, including but not limited to, a criminal background check. We consider qualified applicants with arrest or conviction records for employment in accordance with all local ordinances and state laws, including the Los Angeles County Fair Chance Ordinance for Employers (FCO) and the California Fair Chance Act (FCA). The background check assessment will consider whether a criminal history could reasonably have a direct, adverse impact on the job-related safety, security, trust, regulatory compliance, or suitability for this role. Such findings may result in withdrawal of a conditional job offer.
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $26.00/hr.