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QC Associate Scientist
1 month ago
Simply Biotech is seeking a highly skilled and detail-oriented QC Associate Scientist to join our team in San Diego, CA.
Job Summary:The QC Associate Scientist will be responsible for performing various analytical and physical testing techniques to support cGMP and development activities. This includes performing required periodic testing, routine testing, and analytical testing of drug products.
Key Responsibilities:- Prepare samples, reagents, and standards for analysis
- Maintain accurate and detailed laboratory records
- Conduct analytical testing using a range of techniques such as HPLC and ELISA
- Perform various forms of periodic and routine testing, such as for the WFI system or the environmental monitoring of classified spaces
- Analyze and interpret various forms of QC data, prepare technical reports, and present findings as required
- Assist in the implementation of new analytical methods via execution of method development, optimization, and validation protocols and activities
- Adhere to standard operating procedures and relevant regulatory and safety regulations
- Collaborate with cross-functional teams to support product development and manufacturing activities
- Develop and review SOPs and other documents associated with the implementation of the microbiological program
- Perform monitoring and/or inspection and control of in-coming components and materials, including establishing the necessary specifications and SOPs
- Support assays via preparation of samples and associated documentation, tabulate and analyze results, and/or work with research animals as required
- Handling of research animals, including but not limited to performing body weights, hair removal, monitoring, etc.
- Participate in laboratory organization and maintenance tasks, such as glassware washing or solvent preparation
- Perform alternate functions and other duties as trained within the company as assigned
- Minimum of 3-5 years biotechnology/pharmaceutical / device manufacturing experience
- Awareness of regulatory requirements in drug development and product life cycle
- Hands-on experience with analytical instrumentation
- Experience with method development and method validation
- Excellent attention to detail and ability to follow protocols precisely
- Strong analytical and problem-solving skills
- Knowledge and understanding of analytical techniques as well as microbiological/scientific terms and terminology
- Manual dexterity for operating laboratory equipment
- Strong aseptic technique
- Good written and verbal communication skills
- Basic understanding of GMP and GLP principles
- Ability to work independently and as part of a team
- Ability to stand for extended periods
- Capable of lifting up to 20 pounds
Simply Biotech offers a competitive salary range of $70-90k and a dynamic work environment that fosters growth and development.
For immediate and confidential consideration, please email your resume to odrow@simplybiotech.com or call 858.251.3562.