Job Responsibilities

• Working with the Wacker Biotech US Quality Assurance to ensure compliance with Wacker Biotech US quality expectations and cGMP's.
• Generation and reporting of Quality Metrics, drafting, review and approval of Control document.
• Assisting in supporting the Quality Management System and other Quality duties.
• Supporting record review and product release, internal/external auditing program, processes and manufacturing suites, the training program and investigation activities.
• Ensure compliance of QA controls with the company's best practices and standards.
• Validation experience (Facility, Utilities Equipment or CSV) is a plus
• Detail oriented and strong communication skills.
• Ability to work in a high pace environment.
• Critical thinking and problem-solving skills.
• Proficiency in Microsoft Word, including editing, formatting, utilizing templates, creating forms, and embedding hyperlinks, and basic experience and competency with Excel and Adobe Acrobat Professional is a plus.
• Experience in working within document control systems is preferred.
• Experience with Electronic Document and Quality Management Systems preferred

Job Qualifications

• BA/BS in a scientific discipline with 5+ years' experience in biotechnology or pharmaceutical industry or MS with 4+ years of experience
• Minimum 4 years' experience in a regulated industry; Quality Assurance role required
• Other requirements include, Excellent organizational skills; ability to work independently and in team environments; understanding of FDA/EU GMP/GCP/GLP Quality Requirements; familiarity with FDA current Good Manufacturing Practices and Good Documentation Practices.
• Through knowledge of GMP, GxP documentation including 21 CFR Part 11 compliance
• Ability to draft/revise and contribute to SOP and reports
• Technical review of validation and quality control documents (ie. Calibration certs, PM, WO)
• Other essential responsibilities as assigned by management
• Tracking and reporting compliance metrics

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