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Job Overview

Perform tasks to support lab data and samples under supervision and direction.

Responsibilities

Receipt of samples from QA. Verification that the information on the sample bottle matches the information on the test request form.

Logging samples into LIMS, generating release and stability reports from LIMS, and creating stability protocols in LIMS.

Organization of samples in the sample management room.

Assist with stability pulls. Assist with labeling and verifying samples to be placed on stability as per approved stability protocol. Place samples in appropriate stability chambers as per approved stability protocol.

Preparation of shipment request forms and boxing of samples for outside testing. Tracking testing performed at the contract lab and following up when necessary.

File and scan data packages as required. Provide data when requested by QA.

Serve as a backup for glassware washing when the primary person responsible is unavailable.

Serve as a backup for the reference standard room when the primary person responsible is unavailable.

Perform other duties as assigned.

Qualifications

High School Diploma, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

Demonstrate ability to obtain the appropriate knowledge from resources on Lean Six Sigma Methodologies and proven analytical/problem solving capabilities.

Demonstrates the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

Must be able to comprehend and follow all applicable SOPs.

Demonstrate ability to acquire the appropriate knowledge from resources on with electronic Quality Management Systems such as MasterControl and Trackwise.

Demonstrate the ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

Good understanding of cGMPs, industry, and regulatory standards and guidelines.

Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

Demonstrate the ability to portray the appropriate level of integrity and professionalism.

Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.

Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.

Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.

Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.

Results-oriented and efficient.

Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.

Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).

Demonstrate the ability to work well in a cross-functional team environment.

Must communicate fluently in English and have legible handwriting.

Physical Demands

Ability to travel between and within facilities to visit staff, operations, and projects, as needed.

Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).

Ability to lift up to 40 pounds on occasion.

Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).