Manufacturing Associate - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we've got the right team for you! In this role, you're responsible for the duties listed below.
Immediate opening for a QC Associate Scientist with a medical device company in San Diego, CA who possesses:
- Bachelor's Degree in a scientific field – biology, chemistry, biotechnology, or biochemistry preferred
- 3+ years of QC experience
- 3.Proficient with HPLC and ELISA
- Experience with GMP documentation – CAPAs, Deviations, etc.
- Experience with method development, validation, and transfer is highly preferred
Email resumes to odrow@simplybiotech.com or call 858.251.3562.
FULL DESCRIPTION: This position is responsible for the performance of various analytical and physical testing techniques for the Quality Control team in support of cGMP and development activities. This includes performing required periodic testing such as WFI testing, routine testing such as environmental monitoring of classified spaces or analytical testing of drug product, preparing samples following aseptic technique, as well as participate in animal care and handling as required. This person will work closely with team members to ensure the quality, safety, and efficacy of our products, while adhering to quality systems and applicable regulations of the FDA and/or USDA.
The selected candidate will be responsible for:
- 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.
The selected candidate will also possess:
- 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
Salary Range: $70-90k
For immediate and confidential consideration, please email your resume to odrow@simplybiotech.com or call 858.251.3562. More information can be found at www.simplybiotech.com
