West Pharmaceutical Services is a company dedicated to improving patient lives through the delivery of life-saving and life-enhancing injectable medicines. This role is a Quality Specialist responsible for ensuring customer specifications and timelines are met, and is accountable for in-process quality control services and support.
Requirements
- Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations and standards.
- Manage and maintain traceable, accountable, password protected, documentation system in compliance with Corporate guidelines.
- Inspects in-process production by confirming specifications, conducting Visual, Dimensional and Functional tests, and communicating required adjustments to required personnel.
- Support batch release by completing batch card review and provide quality document control oversight on documentation and reports.
- Approve batch records against approved specifications, quality standards, company procedures and regulatory filings for release of product to market.
- Collaborate with teams on the development of product development DHF documents, specifically in regard to facilitating document control activities.
- Contribute to and support the development of product development QMS procedures and work instructions.
- Calibrates all equipment gauges, measuring devices, weighing devices and hand-held gauging devices.
- Identify, define, monitor, track, and report on documentation metrics (e.g., documentation release rates, documentation rejection rates, etc.).
- Responsible for identification, front line management and appropriate escalation of major and critical incidents.
- Generate associated OOS/Deviation/Non-Conformances.
- Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities.
- Leading the process of the approval of all graphic and label related raw material.
- Establish routine communication strategies for project tracking and prioritization.
- Drive continuous quality improvement efforts to reduce scrap, cycle times, improve efficiency, and eliminate waste.
- Responsible for conducting Production floor GEMBA walks.
- Compliance to all Environmental, Health and Safety regulations.
- Compliance to all company policies, procedures, and corporate policies.
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
