- Title: Sample Management Associate Scientist
- Code: RCI-9108
- Location: Summit New Jersey (NJ) 07901
- Posted Date: 02/11/2020
- Duration: 12 Months
- Name:Mittal Mandavia
- Email: firstname.lastname@example.org
- Phone: 908-704-8843 ✖ 245
Note: The contractor will also be performing scheduling of samples and writing deviations and CAPAs that pertain to Sample Management.
This is normal business hours 8 hours a day with flexibility on which days they need to work. This is the CAR T Team in S12 which is a 7-Day a week working facility.
Purpose and Scope of Position
The Associate Scientist for QC Sample Management works with supervision and is responsible for the movement of samples and materials in support of the CAR T Quality Control laboratories. This includes, but is not limited to, sample collection and distribution, inventory control, maintaining chain of custody and sample tracking. The position is in a regulated environment following current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs) and aseptic techniques.
This position will work weekends, weekdays and some Holidays to support a 7 day a week operation in CAR T. This position is usually 8 hours per day; 40 hours per week; on a flexible schedule.
Required Competencies: Knowledge, Skills, and Abilities
• Experience with sample storage and transfers
• Ability to work on weekends or weekdays with flexible shift hours
• Experience with LIMS sample management system; or equivalent is helpful
• Experience with WORD, PowerPoint, Excel is helpful
• Ability to don appropriate gowning and work in classified cleanroom environment
• Ability to work in a collaborative team environment
• Prior experience and ability to follow and apply Global Regulatory and cGMP requirements
• Ability to adapt and adjust to changing priorities and to meet deadlines
• Ability to follow, review and revise SOPs
Duties and Responsibilities
• Responsible for movement of QC biological test samples including receipt, storage, distribution, transfer and disposal
• Maintain sample tracking and chain of custody records in accordance with cGMP requirements and written procedures
• Ensure that expired samples/materials are destroyed/disposed of according to written procedures
• Performs sample queries and periodic storage reports as required
• Assist management with investigations and deviations related to sample management
• Collaborate with teams to identify and implement process improvements
• Support sample management metrics
• Facilitate cold chain sample transfers as required
QC Lab Inventory
• Assist with maintaining inventory of lab supplies, reagents, media, consumables, etc.
• Liaise with supply chain, warehouse and lab services to ensure supply stocks
• Ensure that materials are appropriately labelled and traceable as per appropriate cGMP, regulatory
requirements, and written procedures
• Assist management with investigations and deviations related to lab inventory
• Maintain 5S and FIFO principles as appropriate
Education and Experience
• Bachelor’s Degree required; preferably in a Science related field
• 2+ years of relevant work experience; preferably in a regulated cGMP environment
• An equivalent combination of education and experience may substitute
• The incumbent will be required to work 40 hours per week, with a combination of weekends and weekdays, on a flexible work schedule.
• The incumbent will be doing light to moderate lifting of objects under 15-20lbs
• The incumbent will be working in a laboratory and clean room environment.
• The incumbent will be working around biohazardous materials, wearing scrubs and other gowning requirements.
• The incumbent should be able to distinguish colors and possess correctable vision to 20/20