Engineer I, Quality

Shiseido • East Windsor, NJ

105d

About The Position

You will be responsible for defining and addressing Quality Improvement opportunities in all GMP areas. You will have extensive knowledge of cGMPs and quality processes and be procedures. You will be accountable for the Annual Product Quality Review (APQR) and investigations for non-conforming products and materials. You will conduct customer complaint investigations and identify solutions.

Requirements

• Up to 2 years of QA/QC experience in pharmaceutical, personal care or cosmetic industries.
• Strong working knowledge of attribute and variable inspections.
• cGMP experience in Internal Auditing processes.
• Bachelor's degree from a 4-year university in either a science or engineering discipline.
• Strong mathematical, technical and problem-solving skills; decision making, data collection and analysis.
• Ability to multi-task and work independently.
• Strong communication and interpersonal skills.
• Solid computer skills with Word, Excel, Visio, PowerPoint, and Outlook.
• SAP or other production system environment experience a plus.

Responsibilities

• Document customer complaints and maintain accurate data.
• Work collaboratively across the organization to conduct, document and present a thorough investigation to appropriate audiences and prepare CAPA to prevent recurrence.
• Carefully manage the receipt, recording and storage of all customer complaint samples in the database.
• Generate the Annual Product Quality Review (APQR).
• Support the preparation of non-conformance reporting, deviation, consumer complaint investigations, and metrics reports.
• Take action to closure on all CAPA implementations, verification and tracking.
• Participate in Internal Quality Audits, reporting observations and other potential concerns to appropriate parties and present findings.
• Provide GMP Training to other departments as needed.
• Research and prepare data needed to support monthly quality metrics reporting.

Benefits

• Medical, Dental, & Vision Insurance
• Life and Disability Insurance
• Paid Time Off
• Paid Volunteer Days
• Paid Company Holidays
• Paid Parental Leave
• 401K with 6% Company Match
• Talent Development & Learning Programs
• Internal & International Mobility
• Product Discounts & Annual Gratis
• Employee Led Affinity Groups
• Tuition Reimbursement

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree