Job Description

ROLE SUMMARY

The CQ Technical Data Reviewer reviews data from physical and dimensional testing of commodities, wet chemical techniques and instrumental analyses. Included in this review are visual evaluations, titrations, pH measurements, AA, HPLC, GC and UV/Vis among other analyses.  In addition to data review, this individual could be responsible for preparing solutions, performing analyses, as well as recording and processing data in accordance with DEA, FDA, and ICH guidelines, as needed.

ROLE RESPONSIBILITIES

• Functions as a dedicated data reviewer for the Chemical Quality Lab.

• Prioritizes data review and testing with guidance from Data Coordinator or supervisor.

• Assists in monitoring laboratory metrics associated with turnaround goals.

• As needed, prepares solutions required for testing, performs analysis, records data according to cGMPs, performs calculations and enters results into LIMS system.

• Provides support to assure lab safety and compliance -either through safe use of chemicals and/or the recognition of DEA, FDA, OSHA, and ICH compliance issues.

BASIC QUALIFICATIONS

• Bachelor of Science in Life Science (e.g. Chemistry, Biology, Microbiology, etc.)

• Minimum of 4 years of experience in a Quality Control or R&D laboratory and experience with a wide variety of analytical techniques (e.g., HPLC, GC, AA, UV-VIS, etc.) and biological techniques (e.g., BET, antibiotic potency, sterility, etc.).

• Knowledge of cGMPs and regulations outside of the US. 

• Good communication, organization and computer skills are required. 

• Knowledge of LIMS, Empower, and Microsoft Office programs is desired.

PREFERRED QUALIFICATIONS

• Minimum of 1 year data review experience with minimum 5 years experience in pharmaceutical manufacturing environment.

• Minimum of 4-5 years of experience reading and interpreting chromatographic data.

• ICP-MS experience preferred

PHYSICAL/MENTAL REQUIREMENTS

Able to: stand for up to 8 hours, sit for up to 8 hours, walk, climb stairs, respond to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective clothing (lab coat, safety glasses, gloves, face shield/goggles, apron), perform repetitive use of upper extremities.

Other Job Details:

Last Date to Apply for Job: January 17th 2023

Eligible for Relocation Package: NO

Eligible for Employee Referral Bonus: YES

Relocation assistance may be available based on the business needs and/or eligibility

Relocation assistance may be available based on business needs and/or eligibility.