The Senior QC Associate (Analytical) is experienced with a wide variety of analytical techniques, international regulations, and method development and validation. This role will lead method transfer, development, and qualification projects. This role is proficient at summarizing data and presenting it to internal and external parties. This role works closely with people at Wacker Biotech USA, our sister sites, and clients, to ensure project commitments are met in a timely manner. This position will mentor other quality associates to support technical transfers, method validation, and quality investigations. This position requires hands-on laboratory work and close collaboration with the QC control team, Process Development Team, and the Operations team, and external clients. This position is expected to be highly knowledgeable of relevant cGMP guidelines, ICH Guidance, and other regulatory considerations.

Essential Functions:

• Perform routine, non-routine and complex analytical testing with independently.
• Develop, qualify, and validate complex analytical test methods following international guidance’s, and client requirements independently.
• Leads QC initiatives. Develop and implement improvement projects seeking input from affected departments / parties as needed.
• Mentors’ other quality control analysts. Ensures personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures.
• 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.
• 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 independently. 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 perform periodic revisions to ensure the procedures are up to date to current standards.
• Assist Quality Assurance in ensuring compliance with applicable quality standards and regulatory requirements.

Position Qualifications:

• Bachelor, Masters, or PhD of Science Degree in the Biological Sciences, Bioengineering or Chemistry with a combination of education and experience performing biochemistry, molecular biology, microbiology, and chemistry.
• 8+ years relevant experience with BS; 6+ years relevant experience with MS; 0+ years relevant experience with PhD
• Ability to travel up to but not limited to 5%.
• The Sr. QC Associate must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills.
• The Sr. QC Associate must be capable of being highly independent, and able to accomplish tasks with minimal input.
• The Sr. QC Associate must be capable of mentoring other quality professionals and working closely with other departments.
• 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.

The anticipated salary range for candidates who will work in California is $110K - $140K. 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