Job Description
Job Description
QC Associate - Simply Biotech
OVERVIEW
Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are 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
- 1+ years of QC experience
- 1+ years of experience with HPLC and ELISA
- Experience with GMP documentation, including CAPAs, deviations, and related quality records
- Experience with method development, validation, and transfer highly preferred
FULL DESCRIPTION: This position is responsible for performing various analytical and physical testing techniques for the Quality Control team in support of cGMP and development activities. This includes performing periodic testing such as WFI testing, routine testing such as environmental monitoring of classified spaces, analytical testing of drug products, preparing samples using aseptic technique, and participating in animal care and handling as required. This role will work closely with team members to help ensure the quality, safety, and efficacy of products while adhering to quality systems and applicable FDA and/or USDA regulations.
The selected candidate will be responsible for:
- Preparing samples, reagents, and standards for analysis
- Maintaining accurate and detailed laboratory records
- Conducting analytical testing using techniques such as HPLC and ELISA
- Performing periodic and routine testing, including WFI system testing and environmental monitoring of classified spaces
- Analyzing and interpreting QC data
- Preparing technical reports and presenting findings as required
- Assisting with implementation of new analytical methods through method development, optimization, validation protocols, and related activities
- Adhering to standard operating procedures and applicable regulatory and safety requirements
- Collaborating with cross-functional teams to support product development and manufacturing activities
- Developing and reviewing SOPs and other documentation associated with implementation of the microbiological program
- Performing monitoring, inspection, and control of incoming components and materials
- Supporting development of specifications and SOPs related to incoming materials and components
- Supporting assays through sample preparation and associated documentation
- Tabulating and analyzing assay results
- Working with research animals as required
- Handling research animals, including performing body weights, hair removal, monitoring, and related activities as required
- Participating in laboratory organization and maintenance activities, including glassware washing and solvent preparation
- Performing alternate functions and other duties as trained and assigned
The selected candidate will also possess:
- Bachelor's degree in a scientific field such as Biology, Chemistry, Biotechnology, Biochemistry, or related discipline preferred
- Minimum of 1 year of biotechnology, pharmaceutical, medical device, or related manufacturing experience
- 1+ years of Quality Control experience preferred
- 1+ years of HPLC experience preferred
- 1+ years of ELISA experience preferred
- Hands-on experience with analytical instrumentation
- Experience with GMP documentation, including CAPAs, deviations, and related quality records
- Basic understanding of GMP and GLP principles
- Awareness of regulatory requirements related to drug development and product lifecycle
- Experience with method development and method validation preferred
- Method transfer experience preferred
- Strong understanding of analytical techniques
- Knowledge of microbiological and scientific terminology
- Strong aseptic technique
- Excellent attention to detail and ability to follow protocols precisely
- Strong analytical and problem-solving skills
- Good written and verbal communication skills
- Manual dexterity for operating laboratory equipment
- Ability to work independently and as part of a team
Physical Requirements:
- Ability to stand for extended periods while performing laboratory and Quality Control activities
- Ability to sit, walk, bend, reach, and move throughout laboratory and office areas as needed
- Ability to lift and carry up to 20 pounds
- Ability to use hands and fingers for pipetting, sample preparation, reagent preparation, documentation, equipment operation, and standard laboratory tasks
- Ability to operate analytical and laboratory equipment safely and accurately
- Ability to work with samples, reagents, standards, solvents, laboratory materials, and research animals as required
- Ability to review laboratory data, test results, technical documents, SOPs, and computer screens for extended periods
- Ability to perform repetitive laboratory tasks while maintaining accuracy and attention to detail
- Ability to wear required PPE and follow all applicable laboratory, aseptic, cGMP, GLP, quality, and safety procedures
Salary Range: $55,000 to $65,000/year
More information can be found at www.simplybiotech.com.
\nCompany Description
Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.
Company Description
Simply Biotech was founded in 2008 and has been repeatedly recognized as one of San Diego County's fastest growing businesses. In 2025, we were named Business Journal's 'Best Places to Work'. Even as our competitors are scaling back and laying off staff, Simply Biotech is expanding to new markets and hiring additional staff in existing offices.