Document Control Specialist - Cambridge, United States - Adecco

Adecco Cambridge, United States

2 weeks ago

Pharmaceutical / Bio-tech

Description

A Document Quality Control Specialist position (fully remote) is now available through Adecco Medical and Science. In this role, you will be responsible for the quality control review of scientific documents within the Translational DMPK and Clinical Pharmacology group. This position will report to the Sr. Manager, QC and Sample Management.

Note that this is a 4-month temp/contract role starting in early June 2024 for a medical leave coverage. This is a fully remote position, but you MUST be located in the Northeast. The work hours are Monday-Friday 8:00am-5:00pm. The pay range is $ /hr. – depending on your level of experience.

Key Responsibilities:

Quality Control (QC) review of Bioanalytical data (LC-MS/MS, ELISA, qPCR, etc.) and study-related documentation generated in-house or at the CROs in support of regulated or non-regulated studies. Ensure that all information contained within the reports is accurate.
review, and edit all documents in SharePoint.
in formatting reports generated in-house and providing report templates to CROs, as needed.
QC review of packing slips, sample manifests, and critical reagent documentation.
in authoring/editing new or approved Bioanalytical lab guidelines.
routine QC review of Electronic Lab Notebooks (ELN) to ensure adherence to guidelines.
audit of finalized reports and maintain errata list.
DMPK trackers for accuracy of entries and consistency of use.
on LIMS system to receive samples and access sample inventory.

Required Skills & Experience:

Bachelor's degree in a scientific or healthcare discipline.

Minimum of 4 years of relevant experience working in a pharmaceutical, CRO, biotech or similar organization preferred.

Knowledge of GxP regulations.

Excellent attention to detail and organizational skills.

Must have excellent oral and written communication skills and demonstrated ability to work effectively in a fast-paced environment where multiple concurrent projects must be completed in a specified timeframe.

Proficient in standard Microsoft Office tools: Word, Excel, and PowerPoint.

Ability to take directions well and multi-task.

Demonstrated proficiency with LIMS/LabVantage and sample management is a plus.

Working knowledge of bioanalytical assays (LCMS/MS, immunoassays, etc.) is a plus.

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