Provides oversight and coordination of study initiation.
Understands protocol language and translates to internal systems and processes.
Prepares for and facilitates internal meetings; attends external meetings.
Acts as the primary coordinator for the receipt and log-in of samples and standards.
Manages shipment requests.
Manages sample and standard workflows, including check-outs, shipping, relog and disposal activities to support laboratory analysis.
Tracks project progress, within assigned client team and associated support teams, provides status updates.
Initiates project set up process.
Manages reagent documents for client and team, including Certificates of Analysis (CofAs) and Safety Data Sheets (SDSs).
Coordinates and tracks the completion of internal lab-based projects, including facility audits and incident reports.
Manages client communication related to sample and standard processes.
Supports the client relationship manager with daily progress updates to ensure project completion.
Manages timelines; identifies and escalates risks as necessary.
Attends internal meetings.
Requirements
Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0+ years) or equivalent combination of education, training, & experience.
Demonstrated experience working in GMP or similarly regulated laboratory environment preferred
Solid understanding of biopharmaceutical testing procedures preferred
Excellent organizational skills with the ability to adapt and adjust to changing priorities while maintaining focus, composure and productivity
Ability to manage multiple assignments with challenging/conflicting deadlines
Proficient in Microsoft suite applications (eg: Word, Excel, PowerBI, PowerPoint, Teams, Sharepoint)
Strong attention to detail and problem-solving skills
Effective written and verbal communication skills
Demonstrated experience in identification and resolution of conflicts in a professional environment
Ability to maintain a high degree of confidentiality with client information and data
Ability to attain, maintain and apply a working knowledge of applicable procedural documents.
Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
Demonstrated ability to receive and apply constructive feedback.
Benefits
healthcare
annual incentive plan bonus
employee benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMPbiopharmaceutical testing proceduresproject managementsample workflowsreagent document managementCertificates of AnalysisSafety Data Sheetslaboratory analysisrisk identificationconflict resolution
Soft skills
organizational skillsadaptabilityattention to detailproblem-solvingeffective communicationconfidentialitypositive attitudeenthusiasmteamworkconstructive feedback