Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance. This role will support manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.
- With a high degree of technical flexibility, work across diverse areas within the lab
- Plan and perform routine analyses with efficiency and accuracy.
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- Troubleshoot, solve problems and communicate with stakeholders.
- Initiate and/or implement changes in controlled documents.
- Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
- Write protocols and perform assay validation and equipment qualification/ verification.
- Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
- Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.
- Approve lab results
- May participate in lab investigations.
- May provide technical guidance.
- May train others.
- May contribute to regulatory filings.
- May represent the department/organization on various teams
- May interact with outside resources.
- Bachelor's degree in a science discipline.
- 3+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
- Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products
- Experience in a wide variety of analytical techniques including but not limited to HPLC, Gels or Capillary Electrophoresis.
- Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deep technical knowledge through exposure and continuous learning
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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