The QC Associate Senior (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 Guidances, and other regulatory considerations.
Essential Functions of this Position
Lead project groups to complete objectives in a timely manner. Manage project related schedules. Collaborates with Operations, Process Development, and external clients. Presents project progress and scientific updates to internal and external parties. Develop, qualify, and validate complex analytical test methods following international guidance’s, and client requirements. Mentors quality control associates. Ensures personnel understand various analytical assays and standard operation procedures as well as conform to any departmental procedures. 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. Lead QC initiatives. Develop and implement improvement projects seeking in-put from affected departments / parties as needed.
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, or 0+ years relevant experience with PhD required Up to 5% travel The QC Associate Senior must be accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills. The QC Associate Senior must be capable of being highly independent, and able to accomplish tasks with minimal input. The QC Associate Senior 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. 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 $106,000.00-130,000.00. 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.
What do we offer? WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions. WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development. 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 We are looking forward to your online application at www.wacker.com.Reference Code: 27818 #LI-CE1 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.