Regenerative Medicine Quality Control Specialist
4 weeks ago
We are a leading regenerative medicine company seeking a skilled Quality Control Specialist to join our team in the advanced and acute wound care space.
The ideal candidate will have a strong background in microbiology and quality control, with experience in performing routine quality control activities in support of product production and releases.
The Quality Control Specialist will interact with other internal departments, including Manufacturing, Quality Assurance, Validation, Calibration, Materials, and Logistics, as well as external entities such as contractors and suppliers.
The successful candidate will perform a wide variety of routine activities to ensure compliance with applicable regulatory requirements, including conducting testing, trending, and reporting results.
Responsibilities will include:
- Performing and reading environmental monitoring, critical utilities, and personnel testing samples
- Performing and supporting microbiological testing, such as plate count enumeration, critical utilities monitoring, endotoxin testing, environmental monitoring, bioburden, and growth promotion
- Performing raw material, intermediate, and non-routine testing
- Preparing and sending out samples for microbiological identification and/or mycoplasma testing
- Participating in high-level quality systems programs, such as excursions, deviations, CAPA, etc.
The ideal candidate will have a strong understanding of cGMP and GLP regulations and compendial requirements, as well as proficiency with computer software necessary to perform data handling tasks and accessing e-mail and filling out reports.
Additional requirements include:
- Handling biohazardous materials and chemicals
- Basic laboratory safety procedures
- Good communication skills, both written and verbal
This is a laboratory-based position with approximately 20% of the week spent in an office setting. The working environment includes working with chemicals such as disinfectants and exposure to human tissue products.
We offer a competitive compensation package, including 401k with a generous employer match, comprehensive medical, dental, and vision coverage, flexible spending account, and education assistance policy.
Organogenesis is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating an inclusive and respectful work environment.
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