Job title: QA Manager QMS Duration: 3+ Months Location: Cambridge, MA, Hybrid schedule with one day per week on-site
Key Responsibilities:
Data integrity and compliance.
Managing submissions, CRO/third-party data, and new drug reports.
Handling transformations of both paper and electronic data.
Ensuring validation and verification processes are followed for pre-clinical and early clinical studies.
Primary Responsibilities
Data Integrity & Verification:
Ensure the accuracy of data related to CROs and third-party reports.
Match, transform, and maintain integrity across paper and electronic data systems.
Pre-Clinical & Early Clinical Focus:
Primarily working on pre-clinical and early-stage clinical studies.
Handle the reporting process, including cross-referencing and method validation.
Maintain zero gaps in data integrity, particularly in scientific reports.
Description
Review of regulated study reports by third parties
Support M&A integration activities
Implement risk mitigation strategy
Perform remote Source Data Verification for non-regulated studies at third parties
Review third party operations
Educational Background:
Bachelor's or Master's degree in a related field.
Open to a broad range of scientific or technical backgrounds but with an emphasis on understanding data transformation and scientific reporting.
Stay away from the words database and statistics etc.
Main responsibility is data integrity, violations, submissions done, new drug report, data, behind those reports around CROs and third parties, verifications.
Skills Required:
Scientific Technical Knowledge:
Ability to handle scientific data and validate reports.
Ideally, the candidate should have publication experience.
Understanding of Drug Discovery:
Basic knowledge of drug discovery and early development processes.
GLP (Good Laboratory Practice) and GCP (Good Clinical Practice) understanding is required
Business/Project Management Skills:
Ability to handle the scientific and technical aspects of project management.
Focus on scientific, technical data analysis rather than statistical data.
Tech-Savvy:
Proficient in MS Teams, MS Office for documentation and communication.
Experience:
Exposure to biotech, pharma, regulatory, or human health industries.
Cross-functional communication experience is required.
Additional Insights
High visibility and high impact due to the involvement in company's pipeline and acquisitions.
Volume of work is currently large, making this role crucial to the team’s success.
Role requires working onsite.
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: $70.00/hr.
