Laboratory Compliance Intern at The Ritedose Corporation in Columbia, South Carolina

Job Description:

The Laboratory Compliance Intern role is to provide quality compliance support activities for the Analytical, Microbiology, and Stability departments. The Laboratory Compliance Intern will be responsible for sample management, ordering and inventory of materials, scheduling/tracking maintenance and calibration of all laboratory equipment, and laboratory hygiene employing 6-S principles to include a focus on safety.

The following characteristics are essential in order to be a contributing team member for the Laboratory Compliance Department: ability to multi-task in a fast-paced environment, open to working flexible hours, ability to adapt to shifting priorities based on department needs, strong GMP documentation and data review skills.

Responsibilities:

• Track and maintain GMP documentation relevant to instruments, chemicals/media, and samples.


• Schedule maintenance and calibration of laboratory equipment while ensuring databases are current. Responsible for tracking and performance of maintenance and calibration of laboratory equipment as assigned. Responsible for routine maintenance and preventative maintenance of laboratory equipment, as applicable.


• Perform Laboratory sample management from receipt to destruction through sample maintenance and tracking.


• Maintain inventory of critical supplies for the Analytical, Microbiology, and Stability departments.


• Document and review of raw and final data to ensure complete and proper documentation according to procedures and applicable cGMPs.


• Assist with laboratory investigations when necessary.


• Assist with and perform revision and creation of internal SOPs pertinent to laboratory compliance.


• Perform document coordination for off-site storage.


• Perform general maintenance of the Analytical, Microbiology, and Stability areas to ensure good housekeeping and a safe working environment with a focus on 6-S. Duties include but not limited to:


• Glassware, Pipets, etc. (cleaning, maintaining)


• Inventory (Lab Supplies, Chemicals, Reagents, Standards, Columns, Media, etc.)


• Housekeeping, cleaning and organizing


• Maintenance of emergency showers and eyewash stations


• Waste removal


• Replace Desiccants.


• Administrative duties


• Data scanning, database entry, coordinating documents ready for off-site storage


• Temperature monitoring of laboratory equipment.


• Responsible for notifying Laboratory Management of issues and working with management to address as appropriate.


• Perform supply ordering and inventory control.


• Utilize LIMs or laboratory software system (including spreadsheets when necessary) for tracking including setup and maintenance of LIMS system when applicable.

Special Project:

• Assist with new Laboratory Information Management system implementation


• Inventory and Document Control System Utilization

• Pursuing degree in related scientific discipline or business management, preferred


• Laboratory experience, preferred.


• Proficiency with current word processing, and spreadsheets, preferred


• Experience with Electronic Documentation Systems


• Ability to participate in and contribute to a team-oriented work environment by developing positive working relationships within the department and between other departments


• A strong sense of ethics and a dedication to adhering to all applicable SOPs and GMP regulations