The QC Associate II (Analytical) position will work as part of the QC team to 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.
Job Responsibilities
- Perform analytical testing following established protocols
- Work with product development and manufacturing on tech transfer activites as well we provide support for commercial manufacturing. This includes testing development materials and performing method qualifications
- Provide laboratory maintenance by performing 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
- 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 perform 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.
Job 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 activities in the pharmaceutical and biotech industry.
- Ability to understand and execute analytical procedures.
- Experience with typical analytical equipment such as HPLC, UV/Vis, CE, Plate Reader, PCR, Osmometer, balance, conductivity meter, pH meter and Gel Imager
- A working knowledge of GMP compliance, pharmacopeia (USP, EP and ICH), and regulatory requirements.
- Accountable for the work performed, productive within the company, provide open communication, and exemplify effective teamwork skills
- The position is responsible in 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 performing analytical testing with 21 CFR compliant laboratory equipment (HPLC, CE, qPCR).
The anticipated salary range for candidates who will work in San Diego is $73,000.00-85,000.00. 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.
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Compensation and Incentive plans
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Medical, Dental, and Vision Insurance effective day 1
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Paid Time Off in addition to personal days and holidays
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Paid parental leave
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Wellbeing fund
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Flexible hybrid work arrangements
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401(k) with company match
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Education Assistance Program
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Career development and advancement opportunities
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Support for Community Involvement
Reference Code: 26522
Nearest Major Market: San Diego