What are the responsibilities and job description for the QC Specialist position at Actalent?
Description:
The Quality Control Specialist performs functions associated with quality control and review of laboratory produced data. The QC Specialist will be responsible for reviewing designated laboratory data packages for completeness, accuracy, and compliance to Good Laboratory Documentation practices. Both electronic and paper data packages will be reviewed within the Quality Control Team. This role will use programs to collect and evaluate data to assist in assessing and documenting results of the quality control processes.
Quality Control Function:
• Review different types of paper and electronic records which are produced within the scientific this will consist of several different types of work streams including but not limited to: ELISA, MesoScale Discovery (MSD), Quanterix, ELISpot and CDx. Focus will be on review of clinical data and/or data related to validation testing These may be in the form of data release, data table summaries or formal reports
o Review to include but not limited to: equipment and reagent expiry status, assay control values, bench sheet information, raw data files and storage locations, analyzed data and storage location, BSI entries as it relates to final data and volume updates
• Assist in maintaining Quality Control systems, actively managing assigned activities (including logging and tracking of events and outcomes), and working with end-users on thorough documentation of errors which are identified during review
• Maintain monthly metrics and reporting tools for all aspects of the QC systems
• Work closely with Scientific stakeholders and Quality Assurance to ensure alignment of the review process for all data
• Review and provide documents and records for audit and inspection requests
Operations Support:
• Actively participate in daily operations to assist in helping meet client deliverables, routing data packages and reports to QA
• Assist in the review of data to help meet customer specifications to conform to contractual requirements
• Work with functional groups to develop correct documentation required to document Good Documentation Practices (GDP) for data which is to be released to a client
Additional Skills & Qualifications:
• Bachelor’s Degree or equivalent combination of education and experience
• 1-2 years of related experience with Quality Control or document review
• Microsoft Office suite proficiency including Office Word, Excel, PowerPoint
• Ability to organize tasks, work independently and adapt to changing priorities
• Ability to function independently in a minimally supervised environment with exceptional attention to detail required
• Demonstrated highly developed communication skills including well-developed writing skills and verbal and interpersonal skills
• Must be able to read, write, speak, fluently and comprehend the English language
WHY ACTALENT
- Work with a dedicated career partner specialized in your healthcare skill set
- We advocate on your behalf so you get what you want and need out of your job
- Get performance feedback, career advice, and access to ongoing professional
- development tools
- Build your career and learn new skills through projects as diverse as your curiosity
- You are eligible for benefits, paid-time-off, and competitive wages that are paid weekly
ABOUT ACTALENT
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Actalent is an equal opportunity employer.
About Actalent
Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.
