Specialist, Quality Assurance

Responsibilities

• Review raw material, packaging material, in-process material, and finished product specifications for GMP compliance
• Reconciliation of OTC Batch Records
• Prepare master production records for all OTC products if assigned
• Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review
• Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment
• Provide assistance writing OOS, Consumer complaint investigation, metrics reports
• Present data through meetings and as written documents
• Propose appropriate CAPAs to avoid reoccurrences
• File and maintain batch production and control records for OTC product
• Conduct Annual Product Review of OTC products
• Approve the BOMs, review CRAs
• Administers CAPA system focusing on CAPA approval, closure and database tracking
• Carry out Internal Quality Audits
• Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports
• Coincide and track completion of action items generated due to deviations and change control requests
• Coordinate and track closeouts of deviations, change control requests, consumer complaints, and out-of-specification investigations
• Assist in any project/task assigned by the Manager

Qualifications

• Bachelor's degree (B. A.) from four-year College or university preferably with a Engineering or Science major
• Two years knowledge of pharmaceutical GMP documentation requirements and quality assurance experience in a regulated industry
• Good understanding of 21CFR (Part210-211), ICH guidelines
• Expert in Excel and PowerPoint presentation
• Good presentation skills
• Excellent demonstration of verbal and written communication skill

Competencies

• THINK BIG û Adapt a big-picture perspective. Deliver new values through creativity.
• TAKE RISKS û Embrace risk. Practice ôTrial & Error & Trialö.
• HANDS ON û Consider front-line realities when making decisions. Take the lead from end-to-end.
• COLLABORATE û Break free from the silo mentality. Leverage the diverse capabilities of colleagues.
• BE OPEN û Be transparent. Create an environment that encourages everyone to speak up û even if it is bad news.
• ACT WITH INTEGRITY û Be sincere and humble at all times.
• BE ACCOUNTABLE û Commit to the goal. Take accountability for the execution.
• APPLAUD SUCCESS û Create a culture that celebrates success.

Company Information

Shiseido is an Equal Opportunity Employer and does not discriminate on the basis of race, color, gender identity, religion, sex, age, national origin, disability, veteran status, sexual orientation, genetic information or any other classification protected by Federal, State or Local law.