QC Associate I-Raw Materials Lab

FAREVA•Richmond, VA

1d•Onsite

About The Position

Performs chemical or physical assays of raw materials, production intermediate and bulk samples. Assays are qualitative, quantitative and investigational in nature and are performed in compliance with USP, FDA and other regulatory body requirements, and Fareva standard operating procedures. Results are compared with specifications and documented. Incumbent has working knowledge of fundamental technical and quality concepts and receives minimal supervision on routine assignments.

Requirements

BS degree in Chemistry, Biochemistry or relevant science discipline; 0-1 year of relevant Quality experience preferably in the bio/pharmaceutical industry.
MS degree in Chemistry, Biochemistry or relevant science discipline; 0-1 year of relevant quality experience preferably in the bio/pharmaceutical industry.
Requires basic knowledge of fundamental quality concepts.
Learns and performs defined procedures.
Working knowledge and practical application of relevant techniques and instrumentation such as: HPLC, GC, TLC, UV/VIS, FTIR/ATR, etc.
Ability to interpret and document test results according to standard operating procedures and using cGMPs; background using LIMS is desirable.
Learns to identify technical problems and solve these under the guidance of management.
Receives minimal supervision on routine work, and specific direction on new work.
Organizes daily activities, including technical aspects, to ensure timely completion of assignments.
Ability to participate on teams comprised of immediate group members or to work cross functionally, if necessary.

Nice To Haves

background using LIMS is desirable

Responsibilities

Conducts assays: Performs chemical or physical assays of raw materials, production intermediate and bulk samples.
Analyzes results: Accountable for the accuracy and validity of test results. Performs mathematical calculations, interprets results, records observations, and performs peer review. Identifies basic technical issues, atypical or out-of-specification test results, instrument malfunctions and methodology problems and participates in the investigation to resolve and correct. Uses LIMS and other electronic documentation systems to collect and manage data. Uses SOPs and problem solving skills to complete assignments.
Lab Support: Schedules daily assignments and ensures appropriate workflow for testing and peer review activities of their lab. Maintains all related records, prepares and records media, buffers, and reagents, etc., and maintains work area in a neat and orderly manner.
SOPs and Administrative: Learns to analyze and interpret project/study/investigation results and findings. Determines next steps under guidance of management in compliance with SOPs and applicable regulations, carries out technical and administrative duties as assigned.