Quality Assurance Specialist

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

 

POSITION PURPOSE 

This position is responsible for the execution and maintenance of key Quality projects and programs within the Quality organization. The incumbent will be responsible for coordination and implementation of Corrective and Preventative Actions, Root Cause Investigations, Product Complaints and Annual Product Review (APR) reporting with cross functional exposure. This position will interact with other operating and staff groups within the North American organization including, but not limited to Quality Assurance, Quality Compliance, Quality Control, Operations, Purchasing, R&D, Regulatory, Engineering and/or Sales/Marketing. 

ESSENTIAL FUNCTIONS AND BASIC DUTIES 

• Captures customer product complaint information and details thoroughly and accurately to provide meaningful investigations and feedback to the business.
• Perform investigations resulting from critical and adverse customer product complaints. Determine root cause and help coordinate actions required for resolution.
• Perform Risk Assessment for investigation determination and escalation associated to product complaints, nonconformances, and laboratory events.
• Support laboratory investigations resulting from Out of Specification Results (OOSs) by conducting Phase II Manufacturing investigations. Help coordinate actions required for resolution.
• Investigate in-process and finished good non-conformances (NONCs) to identify root causes of production non-conformances. Help coordinate actions required for resolution and/or CAPA escalation.
• Manage Corrective and Preventative Action (CAPA). Assist with CAPAs to identify root causes of (systemic) issues to help assign appropriate corrective and preventative actions.
• Manage Planned Deviations. Ensure planned deviations are initiated with appropriate information and according to procedure, as well as proper approvals followed by tracking for on time closures.
• Review and approve Graphics, Manufacturing Instructions, Specifications, Master Batch Sheets and other documents as requested.
• Leads and provides oversight, guidance and services with respect to the quality management system to measure, report, and promote conformance to policies and procedures, performance goals, and all applicable quality regulations and standards
• Provides Compliance support, which may include, but is not limited to, the following:
• GMP and quality systems training,
• Preparation and support with front room and/or back-room activities associated to Third Party audits and Regulatory inspections
• Gap assessments against SOPs, regulations, and industry standards.
• Participates in internal quality audits and lean initiatives such as GEMBA.
• Duties and responsibilities may be amended as needed in order to support efficient company operations

PERFORMANCE MEASUREMENTS

• On time performance of root cause investigations
• On time closure of NONC and CAPA (investigation phase or verification phase)
• On time closure of Customer Product Complaints
• On time closure of Planned Deviations
• On time closures of Annual Product Review (APR) reporting

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor’s degree with a scientific discipline

REQUIRED KNOWLEDGE:

• Working knowledge of drug and medical device cGMPs.
• Thorough knowledge of the complaint, nonconformance and CAPA processes, including investigation and root cause analysis.
• Proficiency in Microsoft Office Suite, SharePoint, Org Charts, LIMS, Master Control etc.); Advanced Excel skills

EXPERIENCE REQUIRED:

• 3-5 years in Pharma or Medical Device industry in the Quality Organization

SKILLS/ABILITIES:

• Effective communication skills (verbal & written)
• Must possess strong analytical skills. Ability to conduct root cause investigations and write effective reports including technical reports and communications suitable for the target audience
• Good analytical and problem-solving skills
• Ability to work on multiple tasks and be able to prioritize workload
• Attention to detail, even when under pressure
• Ability to interact professionally with all levels of staff and management and customers.
• Able to gather information from a variety of sources, analyze information, and report results.
• Able to work productively independently with minor supervision
• Self-motivated, flexible and dependable.

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.

SALARY RANGE

• $85,000 - $95,000 annually

PDI is pleased to offer a comprehensive and affordable benefits program to our associates, which includes:

• Medical & prescription drug coverage
• Dental / Vision plan
• 401(k) savings plan with company match
• Basic and supplemental life insurance
• Flexible Spending Accounts (FSAs)
• Short- and long-term disability benefits
• Health Advocacy Program / Employee Assistance Program (EAP)

Many other voluntary benefit plans such as: Legal assistance, critical illness, hospital indemnity and accident coverage, discounted home/auto/rental insurance, employee discounts and pet insurance 

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide:  Sick leave, generous vacation and holiday time, paid parental leave, summer hours, flex place/flex time options