QC Associate II - Development

  Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.   To strengthen our team in San Diego, we are looking for you as a(n) QC Associate II - Development.

 

The QC Associate II (Analytical) position will work as part of the QC team to support method transfer, development, qualification, and validation. The candidate will also 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, and Quality Assurance.

 

Essential Functions of Position:

• Develop, qualify, and validate complex analytical testing following international guidance’s, and client requirements with supervision.
• Perform analytical testing following established SOP’s
• Perform QC activities, organizing and prioritizing daily tasks, related to operations, technology transfers, analytical testing and validation including equipment and procedures.
• 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.
• 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.

 

Position 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 of 2 years of experience performing quality control and/or development activities in the pharmaceutical and biotech industry
• Minimum of 5% travel
• Strong understanding of analytical instrument principals and application of advance instrumentation analysis for pharmaceutical and biologic products which could include HPLC, UV/Vis Spectroscopy, qPCR, Capillary Electrophoresis, Bioanalyzer, Place Readers, Gel Imagers, etc.
• In-depth experience related to method development, optimization, validation, and tech transfers
• Demonstrated ability to manage and work independently on projects, and review project data and provide summary analysis reports based upon the data.
• A working knowledge of GMP compliance, pharmacopeia (USP, EP and ICH), and regulatory requirements.
• Strong communication skills, both written and verbal in the English language, and outstanding interpersonal skills are essential job requirements.
• Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• Knowledgeable using Microsoft Office as well as developing any documentation and creating tables for laboratory inventory and data entry.
• Highly organized, detail oriented, with excellent record keeping skills.
• Strong scientific, analytical, problem solving, and communication skills as well as sound judgement, with the ability to work both independently and effectively with others.
• Experience working in a GMP facility is highly desirable.<