Senior Quality Assurance Associate

Job Summary: Responsible for conducting global corporate audits/inspections of GMP, GCP, GLP sites, data, reports and systems on behalf of Astellas. (APUS). Provides technical expertise to define and resolve QA/QC issues. Assures GxP systems are in compliance with applicable FDA and ICH regulations and internal standards.Job Responsibilities: Conducts audits/inspections of clinical study sites, vendors/contractors, APUS internal systems/procedures and others as required. Performs and distributes formal reports in a collaborative manner. Prepares and finalizes audit/inspection (A/I) reports and draft improvement plans. Updates related databases in a timely manner. Generates status reports as required. Identifies major issues and prepares formal corrective action plans to be approved by the respective management department head and the head of QA. Conducts and coordinates QA assessments of IND/NDA critical documents, annual reports, material review board data, SOPs, initial drug shipment authorizations and other assessments as assigned; maintains related records and tracking systems. Performs QA assessments of Clinical Supply Packaging and Labeling Batch Records. Assures compliance with corporate policies, SOPs and regulatory agency standards. Identifies issues and initiates corrective action where and when required. Conducts and coordinates compliance and quality training to peers, other APUS departments and external customers as requested. Assists in the coordination of recalls and regulatory agency inspections as directed. Integral QA representative in numerous APUS product project teams. Participates in working teams to provide direction regarding quality and compliance. Assists in the review and assessment of validation protocols and reports. Assists in the support of QA Labeling functions.
Experience:
Knowledge of GMP, GCP, GLP and other regulations as required.
Must demonstrate effective communication, writing, and interpersonal skills.
Must keep up to date with new regulations and guidelines to be effective in this position.
Minimum B.S. with at least 3 - 5 years in Quality position within pharmaceutical environment or healthcare field.
Must understand System, process control, ISO 9000, ASQ standards, SOPs/CPs.
GMP auditing Experience required - Pharma / GCP + CLP Auditing Experience Desirable. Sterile Product Manufacturing experience desired. Familiarity with validation, labeling and clinical supply package systems desirable. REQUIREMENTS
Skills: Good Laboratory Practices GLP, Good Manufacturing Practices GMP, ISO 9000 Compliance Documentation, Process Control Analysis, Process Validation, Quality Assurance Audit QAAU, Certified Quality Auditor CQA, Verbal Communication Skills, Written Communication Skills