Quality Assurance Specialist Ii

Job Responsibilities

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

Job Qualifications

• Ability to draft/revise and contribute to SOP and reports
• Technical review of validation and quality control documents (ie. Calibration certs, PM, WO)
• Tracking and reporting compliance metrics
• 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.
• Minimum 4 years' experience in a regulated industry; Quality Assurance role required
• Through knowledge of GMP, GxP documentation including 21 CFR Part 11 compliance
• BA/BS in a scientific discipline with 5+ years' experience in biotechnology or pharmaceutical industry or MS with 4+ years of experience
• Other essential responsibilities as assigned by management

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