Product & Quality Assurance Analyst

About the Role

Key Responsibilities

• Review of Product Information: Perform product reviews on a scheduled yearly basis to meet site and regulatory requirements, evaluate processes, locate corrective actions, and suggest improvements.
• Assimilate and interpret large amounts of data (products, manufacturing processes, businesses, regulations, etc.) and suggest improved and more efficient methods of working.
• Preparation and review of GMP documentation related to product reviews.
• Ensure records are kept in accordance with legal requirements as well as Croda internal requirements.
• Entry of product reviews in eQMS audit application, assignment of response tasks.
• Update and/or completion of regionally specific DMF as required.
• Perform internal audits and support internal auditing program by acting as a QMS/GMP resource, which may include lead auditor responsibility.
• Assist with customer and management system certification audits as a site QMS/GMP resource.
• Support vendor management activities by performing vendor audits as required.
• Entry of audits in Intelex audit application, assignment of response tasks, obtaining responses from managers, and compiling responses into site-level response documents.
• Entry of CAPAs into Croda Inc Improvement Plan application.
• Manage site pest control program.
• Manage site quality service provider list(s), including confirmation of vendor quality certifications and execution of quality or service agreements.
• Support site validation activities including preparing documentation and maintaining appropriate records.
• Support QMS training, participate in GMP compliance activities, facilitate complaint processes, and support investigations.
• Collect data for QMS annual management review and analyze data efforts.
• Support other quality assurance functions as needed to ensure effective execution of the quality management system.

Requirements

• Bachelor degree in chemistry or related technical field.
• Must have written and oral proficiency in the English language.
• 2-3 years of specialty chemical experience including a strong technical background and experience with DMF and product review analysis.
• 2-3 years of experience with quality regulatory environment ISO 9001/EFfCI/EXCiPACT/cGMP/FDA within a GMP manufacturing environment.
• Ability to work under tight deadlines and maintain relationships with individuals across multiple departments and regions.
• Ability to prioritize work and work independently.
• Good problem solving and critical thinking skills.
• Excellent writing and communication skills, including the ability to formulate responses in statements and reports.
• Experience working with individuals from multiple countries and languages.
• Proficient with Microsoft Office programs; experience with SAP is desired.

Nice to Have

• Experience with SAP.

Benefits & Perks

• Competitive salary and benefits package including medical, dental, and vision coverage.
• Generous PTO.
• 401K match.
• Wellness reimbursement.
• Parental leave.
• Career development opportunities.
• Company paid and voluntary Life and AD&D Insurance.
• Short and long-term disability coverage.
• Paid holidays.