Senior Associate Scientist, Quality Control

Job Title - Senior Associate Scientist, Quality Control

Work Location - Cranbury NJ

The QC Associate Scientist-Operations will be responsible for QC inventory management to support QC GMP activities, including but not limited to QC lab supplies ordering, receiving, storage, distribution, and inventory tracking. This person will also be responsible for QC document issuance, retrieval, reconciliation and archival. This personnel will also support QC lab 5S work, QC office supply management, QC house keeping, sample/reference standard management, and stability study program. Demonstrates strong communication and time management skills.

• Responsible for QC lab inventory management, including but not limited to QC lab inventory ordering, receiving, storage, distribution, inventory tracking by using either paper-based forms or LIMS inventory module, and generating inventory-related monthly report.
• Maintain all QC inventory stock room well organized and clean by using 5S strategy .
• Support QC operation lab 5S work.
• Responsible for QC disposable lab coat and safety goggle management, including but not limit to ordering, receiving, storage and refill the cabinet to support audit, and used goggle cleaning to support both QC analyst daily use and auditor use.
• Resposnsible for QC document retrieval, issuance & reconciliation to all QC functional groups in a timely manner.
• Work closely with QA to store, retrieve and archive QC GMP documents in a timely manner.
• Support QC sample management as backup sample coordinator, including but not limited to sampling plan review, sample receiving, aliquoting, labelling, storage, and distribution for testing.
• Support project reference standard (RS) management, as backup RS coordinator, including but not limited to RS receiving, aliquoting as needed, labelling, storage, and distribution for testing.
• Support stability study program as backup stability coordinator, including but not limited to stability study protocol review, stability sample aliquoting, labelling and storage for study initiation, stability sample pulling, aliquoting, and distribution for testing.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Perform other tasks assigned by manager as needed to support QC operation.

Technical Skills / Knowledge:

• High school certificate. full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
• 0-2 years of relevant experience or equivalent experience.
• Strong communication skills, both written and verbal, and outstanding interpersonal skills.
• Be skilled at reading and understanding of GMP documentation.
• Good computer operation skills, intermediate level in Microsoft Word, Excel, PowerPoint etc.
• Must be trained or have experience to meet the GMP regulations of NMPA, EMA and FDA, etc.
• High awareness of confidentiality and responsibility.
• Detail oriented and effective time management.
• Be able to work independently as well as a good team player.
• Strong thinking, planning and problem solving skills.
• Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills).

• Must be able to collaborate with clients and internal, and support cross functions to achieve alignment and work effectively.