Perform Quality Control testing of Finished Products and Raw Materials to support clinical and commercial manufacturing requirements. This position will perform QC testing to support manufacturing needs on evenings and weekends, in addition to several weekdays. In addition to the skills and abilities necessary to perform the testing of assay materials, this position requires the applicant to have strong documentation and failure investigation skills. Applicant must be experienced in performing data review and ensuring that data generated meets all technical requirements, and is compliant with FDA Quality System Requirements (QSRs) and ISO 13485 standards. This position requires a Bachelor's degree in an appropriate field of science, with relevant experience in real time PCR, analytical methods and instrumentation, preferably in the In Vitro Diagnostic (IVD) and/or medical device industry.
This position will provide weekend and swing shift coverage.
Swing shift: 12:00 pm - 9:00 pm
Work week: (SAT, SUN, MON, TUE, WED) or (WED, THUR, FRI, SAT, SUN)
- Activities performed must be in concordance with FDA Quality System Regulations and ISO standards.
- Perform QC testing of finished products and incoming materials to support clinical and commercial manufacturing requirements with tight turnaround times.
- Perform data entry and data analysis, to evaluate test results.
- Perform technical review of data generated by the QC group for GMP compliance, compliance to internal standards, and specification requirements.
- Will work on special studies, such as validation and equivalency studies, while supporting a demanding manufacturing schedule, as required by the business needs.
- Must be able to thoroughly train QC team members on methods and instrumentation used in the QC laboratory.
- Create and/or revise QC documents relating to Quality Control testing procedures for improvements and compliance.
- Responsible for contributing to the development and maintenance of department standards and procedures.
- Independently perform and document laboratory investigations and material investigations per internal procedures. Work with external departments as required to determine the root cause of non-conformances and/or to evaluate any potential risks to the customer.
- Bachelor's degree in Biochemistry, Molecular Cell Biology or similar field.
- Minimum of 4-5 years of Quality Control experience.
- Previous applicable industry experience is required.
- Experience working within ISO or GMP compliance, and past experience in a FDA regulated field.
- Effective problem solving and analytical skills is a must.
- Exceptionally strong team player with excellent interpersonal and communication skills, and experience working with junior team members in a mentoring capacity.
- Proficient working knowledge of laboratory instrumentation.
- The successful applicant must be able to work with minimal supervision in an evolving and complex environment.
- Must be able to make independent decisions within expertise and authority level.
- Must be able to train others in technical testing area.
- Have experience handling biological and chemical materials (PCR reagents, buffers, etc.)
- Must have (or be willing to get) required immunizations, in order to work with Bloodborne Pathogens.
- Detail oriented with strong organizational skills, and high quality standards.
- Proficiency in basic computer skills (Excel, Word, PowerPoint, etc.).
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