The Quality Control Associate and Archivist is responsible for review of facility and study data for consistency, accuracy, and completeness.
The QC Associate will also assist in the management, operations and procedures for archiving in accordance with established Standard Operating Procedures, and the Principles of GLP.
This role requires the ability to work closely and communicate effectively with all levels of the organization.Responsibilities:Review of completed forms, reports, tables, and other documents for completeness, consistency, accuracy, adherence to the protocol, adherence to applicable SOPs, and adherence to the GLPs.
Ensure corrections have been implemented prior to issuance.Review study data and draft reports for non-GLP & GLP studiesScan and organize correspondence, and raw data, and other documents into eQCM.Maintain inventory of archived study materials to include paper data, tissues, blocks and slides.Monitor tissue archives to ensure proper storage conditions are maintained.Prepare and distribute disposition requests for study data that has passed the agreed on archival period.Review SOPs to ensure compliance to applicable regulationsOther duties as determined by managementRequirements:Ability to perform duties and responsibilities with minimal supervision.Ability to understand Standard Operating Procedures (SOPs) and study protocols.
Ability to document legibly.Able to stand for extended periods and lift a standard bankers box of files, approximately 25 lbs.Good listening skills essential.
Must be able to elicit precise information from persons with varying professional expertise.Prior experience with Good Laboratory Practices a plusPrior experience with a LIMS system a plusEducation:Bachelor’s degree in pharmaceutical sciences/pharmacology, toxicology or life sciences.Must be proficient in Microsoft Office (Word, Excel, and Outlook).Must be fluent in EnglishExperience in a laboratory setting desired.BenefitsAbsorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a comprehensive benefits package that meets their personal needs.About Absorption Systems, a Pharmaron CompanyAbsorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices.
Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situ and in vivo models to assess the properties in question.
The company’s mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur.
Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally.
We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers.
Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation.
The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals.
Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.Absorption Systems is proud to be an Equal Employment Opportunity and Affirmative Action employer.