Responsible for conducting routine and non-routine analysis of raw materials, in-process, and finished goods under limited supervision and according to standard operating procedures. Becomes proficient at operating instrumentation; including cytometers, HPLC instruments, thermocyclers, DNA Sequencers. Works on problems of moderate scope. Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained. Exercises judgment within defined practices to determine appropriate action. Normally receives general instructions on routine work, detailed instructions on new assignments.

PRIMARY DUTIES:

1. Conducts tests on raw materials, in-process, and finished goods as assigned.
2. Compiles data for documentation of test procedures and prepares reports.
3. Calibrates and maintains equipment.Troubleshoots equipment and reports problems to QC Manager.Maintains logs and required documentation as necessary.
4. Performs biochemical, immunological, and other assigned assays on in-process and finished product to determine conformance to approved QC specifications.Presents test results to designated QC personnel for evaluation and approval.
5. Recommends changes or modifies existing procedures or specifications and writes Change Orders (CO's) as required.
6. Prepares supplies and reagents, and assists with laboratory maintenance as needed.
7. Writes Non-Conforming Material Report (NCMR/QM) with recommendations for disposition and corrective action.
8. Trains and becomes proficient in the operation of the QC cytometers, NGS and Genomics Techniques & Instruments and software packages associated with data analysis.
9. Performs special experiments to evaluate products under direction from Senior QC Chemists or scientists from other departments.
10. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements. Participates as required in training on regulatory issues affecting own area of work. Brings regulatory compliance questions/issues to the attention of management.
11. Promotes a safe work environment. Provides recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices.
12. Performs other related duties and assignments as required.

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EDUCATION AND EXPERIENCE:

• Typically requires a BS in a related scientific discipline, Biology, Biochemistry, Molecular Biology and two years of related experience in an industrial or research laboratory, or equivalent combination of related education and experience. Knowledge of Genomic techniques.
  • BS Degree in Biology, Biochemistry, Molecular Biology

• Able to perform with minimal supervision
• Incorporates GMP and GDP practices into work
• Able to assume increased responsibility outside of regular manufacturing
• Effective written and oral communication skills.
• Analytical, technical, organizational, and problem-solving skills.
• Working Knowledge of Word, Excel, Power point, Visio
• Effective interpersonal skills.
• Familiarity with operation of general laboratory instruments, e.g. HPLC, Fluorimeter, Flowcytomers
• Knowledge of NGS and Genomics Techniques & Instruments:
  • PCR, Thermocyclers, Illumina Sequencer, TAPE Station, Nano Drop, Agilent bio analyzer
• Knowledge of general laboratory safety.
• Ability to follow established policies and procedures.
  

Optional:

• Clinical Genomics experience