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Sr. QC Associate (Development) - 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 Sr. QC Associate (Development) in San Diego, CA who possesses:

• 4 to 7 years of relevant experience in Quality Control, Analytical Development, Process Development, or a cGMP-regulated biotechnology, pharmaceutical, or biologics manufacturing environment
• Experience with data collection, technical writing, report drafting, and SOP writing
• Bachelor's degree in a relevant scientific field required; master's degree preferred

FULL DESCRIPTION: We are seeking a Sr. QC Associate to support analytical development and quality control activities in a cGMP-regulated biotechnology environment. This temporary role is responsible for supporting analytical testing and development activities, collecting and reviewing data, drafting technical reports, writing and updating SOPs, troubleshooting method or testing issues, and supporting documentation within quality systems. The ideal candidate will have strong QC or analytical development experience, technical writing skills, and the ability to work collaboratively in a fast-paced onsite lab environment.

The selected candidate will be responsible for:

• Supporting analytical testing and development activities for biologic products
• Collecting, reviewing, and organizing analytical data
• Drafting technical reports and submitting documentation through internal systems
• Writing, reviewing, and updating SOPs as needed
• Supporting data analysis and documentation related to analytical testing
• Helping ensure analytical platforms, methods, and documentation are ready for assigned work
• Selecting and following appropriate methods for assigned analytical activities
• Reviewing completed lab work and supporting next steps for reporting or documentation
• Identifying deviations, issues, or testing concerns and supporting resolution
• Troubleshooting analytical, documentation, or process-related issues as needed
• Supporting method development, qualification, transfer, troubleshooting, and lifecycle management activities
• Collaborating with QC, analytical development, and cross-functional team members
• Supporting cohesive teamwork within a small QC analytical development team
• Maintaining accurate documentation in accordance with cGMP expectations
• Supporting testing and characterization activities for biologic products as needed
• Performing other duties as assigned

The selected candidate will also possess:

• Bachelor's degree in Biology, Microbiology, Biochemistry, Molecular Biology, Biotechnology, Chemistry, or a related scientific discipline required
• Master's degree in a relevant scientific field preferred
• 4 to 7 years of relevant experience in Quality Control, Analytical Development, Process Development, or a cGMP-regulated biotechnology, pharmaceutical, or biologics manufacturing environment required
• Experience with data collection, technical writing, report drafting, and SOP writing required
• Experience supporting analytical testing and development activities for plasmid DNA, recombinant proteins, vaccines, gene therapies, or other biologic products preferred
• Demonstrated experience with method development, qualification, transfer, troubleshooting, and lifecycle management of analytical methods preferred
• Hands-on experience with one or more analytical techniques preferred, including UV-Vis spectroscopy, HPLC/UPLC, SEC-HPLC, RP-HPLC, IEX-HPLC, HPLC-CAD, capillary electrophoresis, agarose gel electrophoresis, SDS-PAGE, Western blot, qPCR/ddPCR, ELISA, endotoxin testing, bioburden testing, residual impurity assays, or protein concentration and characterization methods
• Experience with characterization and testing of plasmid DNA quality attributes preferred
• Experience with characterization and testing of protein quality attributes preferred
• Strong technical writing and documentation skills
• Strong analytical and troubleshooting skills
• Ability to identify deviations and support resolution
• Ability to work collaboratively with a small team
• Ability to manage assigned work in a fast-paced cGMP environment
• Ability to work 100% onsite in San Diego, CA
• Ability to support a temporary assignment anticipated to last 3 to 6 months, with possible extension
• Ability to work Monday through Friday during standard business hours with some scheduling flexibility

Physical Requirements:

• Ability to sit, stand, walk, bend, reach, and move throughout the laboratory or office environment during the workday
• Ability to use hands and fingers for sample handling, documentation, typing, data review, and standard laboratory or computer-based tasks
• Ability to review analytical data, reports, SOPs, technical documentation, laboratory records, and computer screens for extended periods
• Ability to work with laboratory equipment, analytical methods, samples, reagents, and related materials as assigned
• Ability to occasionally lift, carry, or move standard laboratory supplies, samples, documents, or equipment as needed
• Ability to work in a cGMP-regulated laboratory or biotechnology environment while following applicable safety, documentation, and quality procedures
• Ability to wear required personal protective equipment as needed

Salary Range: $45 to $55/hour
More information can be found at www.simplybiotech.com.