Target PR Range: 19-22/hr
*Depending on experience Contractor 1 -
Support Sample Management (e.g. Biological and/or chemical samples for Release, Stability, File Retention) and Stability Study Management tasks. Responsibilities include:
- Receiving pharmaceutical product samples, which involves physically lifting and placing incoming shipments into designated areas, opening packages and verifying contents, documenting into electronic inventory systems, notifying stakeholders of received samples, and troubleshooting shipment errors.
- Distributing samples, which involves removing from stability chambers samples scheduled for testing, coordinating sample labels, packing samples into appropriate containers per specified storage/shipping conditions, adding appropriate documentation, physically delivering samples to designated locations or coordinating international and domestic shipments, initiating electronic shipment requests, and coordinating with recipients.
- Maintaining samples, which involves locating samples identified for discard, moving samples shelf-to-shelf, chamber-to-chamber, updating sample location in electronic inventory system, and assist team members with various studies and requests.
- May setup and/or review specifications, QC release workflow and/or stability studies in LIMS and perform various other GxP support activities supporting Analytical R&D.
- Use of various electronic inventory and data management systems (e.g. Laboratory Information Management (LIMS), Electronic Lab Notebook (GRE ELN), TRACK, SAP).
- Assist with LIMS and chamber related incident management and metrics activities.
- Ensures safety and GxP requirements are met when performing tasks.
- Ensures timely and GxP compliant delivery of high quality precise data and documentation.
Hands on training will be provided for all tasks.
Qualifications:
• Required:
o Bachelor's Degree in Scientific or Engineering field, or equivalent education.
o Strong interpersonal and communication skills
• Preferred:
o Experience in LIMS Contractor 2
Support Sample Management (e.g. Biological and/or chemical samples for Release, Stability, File Retention) and Stability Study Management tasks. Responsibilities include:
- Receiving pharmaceutical product samples, which involves physically lifting and placing incoming shipments into designated areas, opening packages and verifying contents, documenting into electronic inventory systems, notifying stakeholders of received samples, and troubleshooting shipment errors.
- Distributing samples, which involves removing from stability chambers samples scheduled for testing, coordinating sample labels, packing samples into appropriate containers per specified storage/shipping conditions, adding appropriate documentation, physically delivering samples to designated locations or coordinating international and domestic shipments, initiating electronic shipment requests, and coordinating with recipients.
- Maintaining samples, which involves locating samples identified for discard, moving samples shelf-to-shelf, chamber-to-chamber, updating sample location in electronic inventory system, and assist team members with various studies and requests.
- May setup and/or review specifications, QC release workflow and/or stability studies in LIMS and perform various other GxP support activities supporting Analytical R&D.
- Use of various electronic inventory and data management systems (e.g. Laboratory Information Management (LIMS), Electronic Lab Notebook (GRE ELN), TRACK, SAP).
- Assist with LIMS and chamber related incident management and metrics activities.
- Ensures safety and GxP requirements are met when performing tasks.
- Ensures timely and GxP compliant delivery of high quality precise data and documentation.
Coordination and Support of Physical Instrument Lifecycle Processes
- Coordinate minor lab engineering upgrades on behalf of lab scientists (e.g. alter gas, electric, HVAC service) – Partners: lab scientists, engineering
- Coordinate Instrument Installations: Ensure lab readiness, coordinate with lab scientists, IT, concierge services, asset management, calibration, and internal services functions
- Oversee simple instrument qualifications
- Qualification protocol drafting
- Work coordination between internal services, lab scientists, and external vendors
- Draft results summaries to cover the above work
- Coordinate/support instrument moves: partner with lab scientists, concierge services, asset management, internal services, engineering
- Coordinate Instrument Retirements: coordinate with lab scientists, IT, concierge services, asset management, calibration, and internal services functions.
Inventory and Compliance Activities
- Lab instrument notation upkeep (red sticker walkthrough, check status stickers, update instrument stickers)
- Lab inventory management (update inputs to electronic inventory tool using Maximo, Cognos, VMP, physical walkthroughs, collaborate with asset coordinator to update Maximo)
- Manage the ARD online scheduling tools (update status, location, add/remove instruments)
- Keep lab-facing lists of red stickered instruments, in-process work, and combined inventory up to date.
Controlled Storage Process Coordination and Support
- Scheduling/coordination of calibration with internal partners and mapping activities external vendor
- Partner with vendor to draft controlled storage mapping protocols
- Support onsite vendor visits for controlled storage (loading system, initial discussions on mapping failures)
- Draft Results summary including Routing Monitoring Point (RMP) justification after qualification activity completion
Computerized System Process Support
- Confirm that computers are configured per approved configuration documents – sign in Quality system
- Preliminary understanding of utilization and data integrity attributes for new software
- Partner with lab scientists to facilitate testing of software configurations and updates Hands on training will be provided for all tasks.
Qualifications:
• Required:
o Bachelor's Degree in Scientific or Engineering field, or equivalent education.
o Strong interpersonal and communication skills
• Preferred:
o Experience in software administration
o Familiarity with analytical chemistry instrumentation
o Experience in LIMS
Interviews – 1 phone screen
1 hour onsite interview.
