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 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.
• Highly organized, detail oriented, with excellent record keeping skills.
• Sound scientific judgement with good communication skills and the ability to work effectively with others.
• Experience working in a GMP facility is highly desirable.
• Experience analyzing plasmid DNA is highly desirable.

The anticipated salary range for candidates who will work in San Diego is $73,000.00-90,000.00. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc . Wacker is a multi state employer and this salary range may not reflect positions that work in other states.

• Compensation and Incentive plans
• Medical, Dental, and Vision Insurance effective day 1
• Paid Time Off in addition to personal days and holidays
• Paid parental leave
• Wellbeing fund
• Flexible hybrid work arrangements
• 401(k) with company match
• Education Assistance Program
• Career development and advancement opportunities
• Support for Community Involvement