Analyst, QC II

San Rafael, CA 94901

Posted: 08/22/2016 Employment Type: Contract Industry: Process Development, Quality , Scientific Job Number: 1912
The Quality Control Contract Analyst, under direct or minimal supervision, is responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.  The Analyst works at first under direct supervision and then independently on assays that he/she has mastered.


The Analyst will be responsible for performing, under direct or minimal supervision, sample testing compliant with cGMP guidelines.  This position requires willingness to undergo training on basic as well as more advanced analytical methods and employs laboratory safety polices at all times.  Work assignments will encompass performing and documenting activities from routine to semi-routine in nature, and require the ability to recognize deviations from the accepted practice.  The analyst will be responsible for the timely completion of assignments.  Good record keeping, organizational, written, and verbal communication skills are essential.  The analyst must be willing to work overtime and weekends as required.

Performs, under direct or minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. 


Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.


Evaluates data against defined criteria/specifications.


Maintains laboratory supply inventories.


Maintains the laboratory in an inspection-ready state.


Provides support for routine laboratory functions/chores for the QC laboratory.


Participates in product/project coordination.


Develops and maintains proficiency in a broad range of trained test methods, ELISA, qPCR, aseptic mamallian cell culture technique, cell based potency assays with transduction, and RP-HPLC.


Assists in the revision of written procedures as assigned.


Assists in the preparation of routine and non-routine study protocols and reports.


Trains other analysts in areas of expertise on basic assays as well as more complex assays that are mastered.


Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.


Interacts with other departments, including but not limited to Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development. 


Effective performance ensures that the Quality Control department and the company achieve the annual objectives with respect to the established goals and budget.  An effective Analyst will perform routine assays so that the effort of other personnel can be applied to non-routine situations or assays that require special attention. The Analyst will begin to apply his/her skills to non-routine samples which may include: process development and validation samples/studies.  In addition, the support functions of the Analyst position maintains the laboratory in a productive and compliant state, further optimizing the utilization of all personnel resources.  The Analyst is expected to spend between 80-90% of his/her time in the laboratory and complete all test records associated with testing when the assay is complete. Test records are expected to be completed in 1-2 business days and turned over for review. If a test does not meet system suitability requirements, the analyst is expected to notify his/her supervisor within one business day so an investigation may be opened in a timely manner. 


At least one year in a cGMP/GLP laboratory; quality control experience is preferred.


Ability to follow written instructions and to perform tasks with direct or minimal supervision.


Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel, LIMS.


Viral/ gene therapy work experience is preferred but not required.


Good written, verbal, and communication skills.


Good documentation skills.


Demonstrates the ability to work independently. 


B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 2-3 years of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.   

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