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QC Associate I- Finished Products Lab
4 months ago
QC Associate – Finished Products Lab
Fareva is currently seeking an experienced QC Associate – Finished Products Lab to join our team in Richmond, VA.
Who we are:
Fareva is a leading contract manufacturer of pharmaceutical and personal care products. Located at intersection of Darbytown Road and Laburnum Avenue in Eastern Henrico County. Employs 600 full time employees. Comfortable climate controlled facility covering over 745,000 square feet.
About the role:
Performs chemical or physical assays of production intermediate and bulk samples, finished product, process & cleaning validation samples, and packaged 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.
What you'll do:
Conducts assays
Performs chemical or physical assays of production intermediate and bulk samples, finished product, process& cleaning validation samples, and packaged 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.
Our ideal candidate:
Education and experience
- BS degree in Chemistry, Biochemistry or relevant science discipline; 0-1 years 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.
Skills and abilities:
- 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.