Associate Scientist, QC Operation

Title: Associate Scientist, QC Operation

Location: Cranbury, NJ

Job Respsonsibilities:

• In charge of QC sample management, including but not limited to sample receiving, aliquoting, and distribution for testing by using either LIMS lot disposition module or paper-based forms if LIMS is unavailable.


• In charge of reference standard (RS) management, including but not limited to RS receiving, aliquoting, storage, and distribution using either LIMS inventory module or paper-based forms if LIMS is unavailable.


• Support MFG/MSAT GMP run sampling plan review for the procedures of QC sample management related, including but not limited to sample submission, aliquoting, storage, and shipment, etc.


• Perform RS inventory checking per reference standard management SOP requirement and generate RS inventory summary report as requested by QC department management.


• Support stability study program as backup stability coordinator, including but not limited to stability study protocol review, stability study initiation, stability sample management, and stability summary report generation.


• Ensure all sample/RS related records and refrigerators/freezers logbook complies with GDP requirements.


• Be responsible for managing/recording sample management daily management and QC operation team 5S/EHS boards and generating related key factor trending figures/reports monthly.


• Maintain all refrigerators/freezers used for sample/RS storage well organized and clean.


• Be responsible for acknowledging refrigerators/freezers alarm sample/ RS storage and transferring sample/RS if necessary due to alarms.


• Work with QCFL to clean up peoject related sample/RS when project is completed in a timely manner according to SOP and related protocol requirements.


• Support QC inventory management, including but not limited to consumbles, chemicals, reagents, and media.


• Support QC office supply ordering.


• 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 team work.

Qualifications:

• 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.

Communication 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.

Education and Experience:

• Bachelor of Science degree and/or advanced graduate degree in (Bio)Chemistry, (Bio)Chemical engineering, Bioengineering, or equivalent field.


• 1-3 years of relevant experience or equivalent for Bachelors’, 1-2 years for Master’s in the Quality Control or related field or equivalent experience.

Salary range for this role:49,700-79,500

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.