Sr. QA Compliance

  Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.   To strengthen our team in San Diego, we are looking for you as a(n) Sr. QA Compliance.

 

The Senior QA Compliance Associate will assume responsibilities associated with the process for the internal/external audit program, investigation, document review and in support of a GMP Quality Management System to ensure compliance to regulatory and internal requirements.  This appointee will be responsible for working closely with Wacker Biotech US Management and Departmental staff in support of the Quality Management System.  This person may support QA operational functions as needed.  This may include document reviews and batch records release.

 

Essential Functions:

• Provide expertise and guidance to resolve compliance issues as it relates to manufacturing, testing and release of product with all WBU policies and procedures in addition to all federal/state/local/global and pharmaceutical laws and regulations.
• Manage, lead and/or perform root cause analysis for investigations, deviations, CAPA, Change Control and provides metric collection for timely resolutions to events, out of trend events, facilities and document Risk Management activities (e.g. FMEA.)
• Identify and implement improvements to the QA processes and systems
• Author, review and approval of WBU policies, SOPs, risk assessments and validation documents
• Oversee the supplier assessment program including audits, supplier evaluation and supplier agreements.
• Assists with planning and conducting internal/external compliance audits. Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Evaluates, analyzes and trends quality indicators.  Then prepares reports of quality operations, productivity as well as monthly quality metrics.
• Actively contribute to a culture of continuous capability development through coaching, mentoring and developing team members.
• Support QA operations to release materials and drug substance/drug product.  Including but not limited to data review, batch record review, etc.)

 

Position Qualifications:

• BA/BS in a scientific discipline with 6+ years’ experience in biotechnology or pharmaceutical industry or MS with 5+ years of experience
• Minimum 5 years’ experience in a regulated industry; Quality Assurance role required
• Ability to travel up to 5%.
• Significant experience and understanding of the requirements of GMP and have the ability to apply knowledge in implementation, monitoring and maintenance to ensure the effectiveness of the GMP QMS
• Through knowledge of FDA and EU regulations, along with GxP documentation and data integrity requirements.
• Support, guide and advise on all aspects of manufacturing, QC and supporting operations within the company as GMP SME.
• Experience in regulatory inspections.
• Must be self-directed and requires an appropriate level of education and experience to make and act upon decisions that impact the site.
• 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 e