I: Job Summary

The Specialist II will provide a broad scope of technical knowledge to independently analyze risk, troubleshoot highly complex issues, support quality systems and plant compliance.  They apply expertise and regulatory knowledge to support change and risk management, including application of scientific and technical innovation as it pertains to Commercial Manufacturing. The Specialist II develops a lifecycle and systems-based approach to the design and implementation of Commercial Quality Systems and process controls. This role frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and cross-functional peers to gain alignment on sound quality decisions on both clinical and commercial GMP-related issues.

II: Essential Functions

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

General

• 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
• Review/support contract negotiations for potential customers (specific to review of sections pertaining to compliance)
• Host and help manage Regulatory and Client Audits, responses and associated CAPA.

Supplier Quality

• Manage Supplier Quality Program
• Develop and revise Quality Agreements as applicable for suppliers providing products or services in support of GMP operations
• Manage supplier notification changes to ensure impact is thoroughly assessed prior to implementation
• Liaise with suppliers in addressing nonconformities through thorough investigations. 
• Maintain a Supplier Corrective Action process and liase with suppliers to resolve quality issues.

Compliance

• Recognize and promote quality and compliance improvement
• Plan, schedule and conduct internal 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
• Develop and lead Product Complaint Program
• Develop and lead Product Recall Program
• Contribute to management of Annual Product Review
• Contribute to the drafting and review of regulatory submissions

Quality Systems

• Maintain Emergents Quality Systems including but not limited to CAPAs, Change Control, Effectiveness Checks and Management Review in support of manufacturing 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
• 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 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects managements assignment of essential functions.

III: Minimum Education, Experience & Skills

• Bachelors Degree in Scientific or related fields preferred
• A minimum of six (6) years of cGMP Quality experience
• Strong Commercial manufacturing experience (Large Molecules) required
• 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.