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QC Associate Scientist
1 month ago
Simply Biotech is seeking a highly skilled QC Associate Scientist to join our team in San Diego, CA.
Job SummaryWe are looking for a detail-oriented and analytical individual to perform various analytical and physical testing techniques for the Quality Control team in support of cGMP and development activities.
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.
