QC Analyst

Our world needs ideas! As one of the world’s most research-intensive chemical companies, we have been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 14,300 employees from 70 nations.

Wacker Biotech, as part of WACKER, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. At our San Diego site, we are currently looking for a QC Analyst to join our growing team.

Job Responsibilities

The QC Associate (Analytical testing) position will work as part of the QC team to provide analytical testing for samples at Wacker Biotech US. This position requires hands-on laboratory work and close collaboration with the Manufacturing, Process Development/Technical support, Quality Assurance and Regulatory Groups.

• Perform analytical testing following established protocols.
• Provide laboratory maintenance by performing monthly routine cleaning procedures to ensure safety of laboratory personnel as well as monitor disposable equipment and reagent supplies to make certain materials are available for use.
• Responsible in implementing any investigations and assist in resolving any out of specification and out of trending results as well as performing and developing any corrective and preventative measures.
• Perform QC activities, organizing and prioritizing daily tasks, related to operations, technology transfers, analytical testing and validation including equipment and procedures.
• Develop and revise SOPs under data integrity guidelines as well as performed periodic revisions to ensure the procedures are up to date to current standards.
• Train and ensure personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures.
• Assist Quality Assurance in ensuring compliance with applicable quality standards and regulatory requirements.
• Work with product development and manufacturing on tech transfer activities as well as provide support to any activities needed for commercial manufacturing.

Qualifications

• Bachelor of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
• A minimum or 2 years of experience performing quality control activities in the pharmaceutical and biotech industry.
• The QC Associate II must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• The position is responsible in performing and demonstrating the highest form of quality in the pharmaceutical industry, understanding the cGMP regulations, and implementing these practices on the work being performed.
• Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
• Experience working in a GMP facility is highly desirable.
• Experience performing analytical testing with 21 CFR compliant laboratory equipment (HPLC, CE, PCR) a plus.

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

Be part of our WACKER family, across all nations!

We are looking forward to your online application at www.wacker.com.
Reference Code: 9350

The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.