QA Compliance & Quality Systems Specialist
The Quality Specialist II is responsible for independent QA oversight of each Quality System in support of commercial product manufacturing at the site and manages activities for one or more Quality System or cross-functional project.
The Quality Specialist II will provide a broad scope of technical knowledge to analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance. They apply expertise and regulatory knowledge to support change and risk management.
- Represent the department in interactions with internal functional units and external contract partners or regulatory officials
- Critically review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request for Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
- Support Supplier Quality Program including conducting Supplier Audits, as assigned
- Develop and revise Quality Technical Agreements and supplier notification of changes to ensure impact is thoroughly assessed prior to implementation and liaise on investigations of nonconformities for suppliers providing products or services in support of GMP operations
- Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
- Plan, schedule and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes and activities in creating the audit plan
- Drive inspection readiness strategy and activities and serve as a subject matter expert in quality systems
- Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team
- Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across company to gain alignment on sound quality decisions.
The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.
Education, Experience & Skills
- Bachelor’s Degree in Scientific or related fields
- A minimum of six (6) years of cGMP Quality experience
- Strong Commercial manufacturing experience (Large Molecules) required
- Quality Auditor, Six Sigma, or equivalent certification/education preferred
- Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
- Expert Knowledge and application of GMP principles
- Excellent communication skills: oral/written and listening
- Excellent facilitation and presentation skills
- Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching,
- Interpersonal skills: team building, consensus building, conflict resolution
- Critical analytical skills, strong verbal and communication skills
- Must be able to critically evaluate data summaries and conclusions
- Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
- Ability to influence without authority across cross-functional organization