- Perform routine and non-routine analytical, biochemical, and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates, and finished goods.
- Analysis of data generated by functional assays.
- Assist with projects around QC process improvements and qualification of changes using project management tools to achieve timelines on multiple projects with a high level of independence
- Participate in developing and validating analytical and functional testing methodology, revising and updating work instructions and supporting documentation
- Collaborate with test method development, LCM, and QA in the transfer of new QC test methods
- Lab execution of experiments for technical support of production testing including OOS (out of specification) and NC investigations, root cause analysis and CAPA activities
- Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) essential
- Experience with writing automation protocols for liquid handling robots such as Hamilton a plus
- Excellent cross-functional collaboration, soft influence, written and verbal communication skills Molecular biology laboratory skills such as multichannel pipetting, PCR, etc. required
- Ability to author and revise work instructions and perform molecular biology assays with little guidance
- Ability to respond quickly to shifting priorities and meet deadlines
Preferred Skills and Experience:
- GMP and FDA experience
- Industry experience with functional analysis QC or method development of molecular-biology-based assays preferred
- Other QC, process engineering, R&D or manufacturing experience will be considered
- Experience in data manipulation and analysis of large data sets using excel, and statistical analysis software such as JMP, minitab, etc.
- Experience with DNA or RNA sample preparation, next-generation sequencing, qPCR, capillary electrophoresis and/or Illumina technology
- Experience with analytical assays and equipment such as UPLC, ICS, LCMS, liquid handling robots, etc.
- Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, etc.) and appropriate application to quality control and manufacturing process change qualification, verification and validation activities
Listed responsibilities are an essential, but not exhaustive list, of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
• Typically requires a Bachelor’s degree and 1+ years of related experience