Sr. QC Associate, Analytical 1

  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) Sr. QC Associate, Analytical 1.

 

The QC Associate II (Analytical) position performs routine and non-routine analytical testing to support Operations, and Process Development at Wacker Biotech US with some supervision. This position may perform method transfers, method development, and method qualification with some supervision. This position will perform quality investigations (OOT, deviation, etc) with some supervision. As part of the QC team, this position will be responsible for maintaining the QC laboratory, including cleaning the area, performing routine preventative maintenance, and ordering supplies. This position requires hands-on laboratory work and close collaboration with the QC control team, Process Development Team, and the Operations team. This position is expected to rigorously adhere to relevant cGMP guidelines, test methods, and SOP’s.

 

Essential Function of this Position

• Perform routine and non-routine analytical testing with some supervision.
• Develop, qualify, and validate moderately complex analytical testing following international guidance’s, and client requirements with supervision.
• Perform routine laboratory maintenance including, 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.
• With some assistance, prioritize daily tasks, related to operations, technology transfers, analytical testing and validation including equipment and procedures.
• Document and investigate any out of specification results, deviations or investigations with supervision. Assist in resolving any out of specification and out of trending results as well as performing and developing any corrective and preventative measures.
• With assistance, develop and revise SOPs under data integrity guidelines as well as perform periodic revisions to ensure the procedures are up to date to current standards.
• Train new analysts on and ensures 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.
• Collaborate with product development and manufacturing on tech transfer activities as well as provide support to any activities needed for manufacturing.

 

Position Qualifications

• Bachelor or Masters of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
• Minimum 2 years experience with a Bachelors degree, 0+ with a Masters
• Up to 5% travel required
• The QC Associate II must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• The QC Associate must be capable of reading, understanding, and adhering to relevant test methods, SOP’s, and industry guidance’s.
• The QC Associate must be knowledgeable in basic chemistry and analytical principles. They should understand basic statistical analysis.
• The position is responsible for performing and demonstrating the highest form of quality in the pharmaceutical industry, understanding the cGMP regulations, and implementing thes