Lab Support Technician

Bora Pharmaceuticals•Maple Grove, MN

6d•$44,000 - $60,000•Onsite

About The Position

The Lab Support Technician will maintain the Quality Control laboratory sample log-in room, including an electronic tracking system for all laboratory samples. Responsible for pulling stability samples from stability chambers daily and storing of retain samples. Processes lab samples from multiple locations, logs into laboratory sample tracking system, and disposes of samples once testing is complete. Demonstrates proficiency in using SAP and the electronic laboratory notebook as it pertains to the sample coordinator position. Enters testing results and drafts stability studies in SAP. Drafts 222 controlled substances forms upon request. Requests, coordinates, and tracks outside testing with contract laboratories, ensuring that reports are received in a timely manner. Individual must be self-starting and have strong organization skills. Responsible for sampling and inspecting raw materials, finished products, labeling components, and packaging components. Documents inspection and sampling activities in an electronic software system. This role will be onsite every day.

Requirements

A High School diploma with 4 years' related experience, such as Manufacturing; ideally in the pharmaceutical industry or medical device.
Has experience or training using Microsoft Word and Excel and preferably SAP.
Must be a self-starter with strong organizational skills and the ability to prioritize several tasks effectively.

Responsibilities

Maintains a safe, clean, organized laboratory sample room.
Processes incoming laboratory and retain samples from all relevant locations. Troubleshoots inventory discrepancies, including collaboration with coworkers in other departments (production, QA) to ensure accuracy of sample reconciliation.
Logs QC laboratory samples into an electronic tracking system. Files samples in the laboratory upon receipt and properly disposes of samples once the analytical data has been released.
Stores reserve samples in the Reserve area. Keeps the Reserve area clean and orderly, monitoring space restraints and flow. Assists with performing cycle counts of finished good reserve samples and supports the investigation if cycle count discrepancies are found.
Drafts stability studies in SAP, performs daily stability sample movements, and assists with reconciliation of completed/terminates studies.
Transcribes data from scientific reports and the electronic laboratory notebook into administrative software (SAP).
Critically evaluates testing results for accuracy and completeness. Identifies atypical and out-of-specification results during data entry and notifies laboratory management.
Samples incoming raw materials, bulk drug products, finished products, and packaging components. Transfers samples to the laboratory.
Inspects raw materials, bulk drug products, finished products, and packaging components per specification requirements.
Aids in maintaining clean, safe working environments in the Inspections area and Sample Rooms.
Assists with supplier corrective action reports and investigations as required.
Assists with Inspection of all labeling components for correctness against the approved proof master (e.g., graphics, barcodes and revision date). Has in-depth knowledge of the proofing and barcode reading software and equipment.
Requests, coordinates, and tracks outside testing with contract laboratories.
Uses the master laboratory schedule and works with management and colleagues to help communicate testing priorities.
Creates inspection plans for investigational samples from other departments.
Completes DEA 222 forms upon request. Understands the importance of following SOPs and regulations as they pertain to controlled substances. Serves as the second check for all documentation involving controlled substances.
Works with department personnel to identify activities that could increase efficiency in the laboratory sample and paperwork flow. Works with management and external departments and vendors to implement approved improvements as identified.
Quickly adapts to workflow changes to meet business needs. Demonstrates an initiative to learn new tasks and embraces change.
Has working knowledge of administrative software (EDMS, SAP, etc.) and has a sound understanding of applicable SAP transactions (e.g. ZLIST, QA32, ZSTABILITY).