Quality Control Analyst IV - San Diego, CA

---

Job description

**QC Analyst IV** - San Diego, CA

**Summary:**

+ The Quality Control Analyst IV will be responsible for analytical testing and data verification supporting both product development and commercial products in cGMP-compliant laboratories and will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of the Manufacturing Quality Systems.

+ A strong background in protein chemistry will be essential to perform and troubleshoot techniques such as HPLC and UPLC techniques

**Responsibilities:**

+ Performs physical testing of routine and non-routine samples with little supervision including but not limited to raw materials, in process testing, API & finished good release and stability testing.

+ Ability to perform qualitative and quantitative assays by following Standard Operating Procedures (SOPs).

+ Conduct, compile, and/or review Out-of-Specification lab investigations, deviations, and corrective and preventive action plans.

+ Work with cross-functional teams to advance projects, maintain equipment, and author documents and reports.

+ Performs calibration performance checks of instrumentation and devices such as, but not limited to balances, pH meter, ovens.

+ Proficient with laboratory instrumentation such as Viscosity, Karl Fischer, UV/VIS, HPLC, GC.

+ Documents, reviews, evaluates, reports, and archives analytical results.

+ Maintains Laboratory Notebooks and Logs as detailed in applicable procedures.

+ Writes and proposes revisions to SOP, Validation Protocols, Lab Reports, and related Forms as needed and instructed by Supervisor.

+ Completes investigations into aberrant data and generation of summary reports for their own work, can apply problem solving techniques in a team environment.

+ Considered a Subject Matter Expert in Procedures for their area, providing training in and out of their department.

+ Maintains a clean and safe work environment and follow all safety policies and procedures.

+ Other laboratory and departmental activities as delegated by management.

**Requirements/Qualifications:**

+ Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 7+ years industry experience or master's degree in Biochemistry, Biotechnology, Biology with 6 years industry experience.

+ Previous experience in a cGMP laboratory.

+ Strong background in protein chemistry and experience troubleshooting analytical results.

+ Demonstrated success at writing, revising, and complying with SOPs, protocols/reports, and QC methods.

+ Experience with OOS and Laboratory Investigations, Deviations, Change Controls and CAPAs in a GMP environment.

+ Experience in the isolation and enrichment of product- and process-related impurities.

+ Demonstrated collaboration skills.

+ Excellent communication and technical writing skills.

+ Ability to collaborate with QC chemists, R&D, and other departments to facilitate management of stability testing.

**_For immediate consideration apply today!_**

**_Questions? Please reach out to Dustin at _**

**_\#TJP2021_SPEC_**

**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

**Why Kelly** **®** **?**

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests-it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

**About Kelly** **®**

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. ()