Analytical Chemist

Analytical Chemist

Skillman, NJ

1st Shift

Full-Time

2-Month Contract (potential to extend)

Compensation: $43-53/hr commensurate with experience

Kelly Science & Clinical is looking for a temporary Analytical Laboratory & Sample Management Supervisor to support a global pharmaceutical, biotechnology, and R&D client in Skillman, NJ. This is a 2-month contract with the potential to extend.

RESPONSIBILITIES

Create and approve product specifications in LIMS (Laboratory Information Management System) based from issued GSS product specifications

Responsible for overall flow and maintenance of the Sample Submission Room as per the site Sample Handling Process

Ensure compliant laboratory chain of custody practices

Receive all samples from External and Internal partners submitted to the NA Analytical Department

Log all samples submitted for analytical testing in LIMS

Ensuring the all samples logged into FUSION are received by the appropriate Analytical Team inside the Sample Submission Room

Manage sample storage within the respective cabinets

Available for Analyst sample receipt

Stability protocol approval for cosmetics/OTC (non -NDA/Med Device/Combination Products) drugs

Responsible for tasks related to stability study and sample management include; intake of samples, labeling of samples, counting samples, documenting and maintaining sample inventory, staging samples for storage in stability chambers, placing stability samples in the stability chambers, pulling samples and delivery to testing labs and assisting in the processing of all related stability documentation required for shipping samples, as needed

Accountability of stability sample inventories, on a daily basis

Accountable for shipping of stability samples to outside testing and storage sites

Prepare all shipping and Customs documentation, including programming, use and monitoring of data from dataloggers (to monitor shipping conditions) and working with North America and Global sites throughout the shipping process to ensure sample delivery and highlight any delays encountered

Populate and maintain stability sample shipping tracking log on a weekly basis and reporting out, this include proactively tracking stability sample shipments to notify appropriate personnel of any shipping delays

Maintain stability tracker, on a daily basis

QUALIFICATIONS

BS in Chemistry (or related field)

Sufficient transferrable experience from a leadership position in a GxP role to fulfill the scope of responsibilities

Analytical Lab hands-on or supervisory experience.

5+ yrs Chromatographic (HPLC/GC)/spectroscopic (UV/FTIR) experience/headspace.

Investigational write-up and GxP document review

Experience working in a Sample Submission Room or similar environment

Experience with LIMS (Laboratory Information Management System)

Strong understanding of laboratory chain of custody procedures

Excellent organizational and time management skills

Ability to work independently and as part of a team

Meticulous attention to detail

Strong communication and interpersonal skills

Proficient in Microsoft Office Suite (Word, Excel, PowerPoint)

Familiarity with stability studies and sample management (preferred)