Quality Assurance Investigator

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 to ensure the generation and completion of robust investigation reports (i.e Nonconformance and Root Cause investigations for Corrective and Preventative Actions (CAPA)). Functional responsibilities include support and execution of root cause analysis and the determination of appropriate corrective/preventative actions as a result of investigation findings. This includes, but is not limited to, providing quality, compliance, and technical feedback/review/approval regarding quality and manufacturing investigations. The incumbent will also support the trending associated with quality and manufacturing investigations, Key Performance Indicators (KPIs) and / or other Quality Metrics, support regulatory and customer audits and interact with the customer to resolve concerns regarding quality and manufacturing investigations. This position will interact with other operating and staff groups within the North American organization including, but not limited to Corporate Quality, Operations, Purchasing, R&D, Site Quality, Quality Engineering and Sales/Marketing.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Responsible for oversight and execution of complex and critical deviations and investigations related to quality and Manufacturing.
• Facilitates generation of clear, concise and thorough investigations by providing sound quality and technical feedback
• Support quality and manufacturing investigations resulting from Out of Specification Results (OOSs) Phase II. Help coordinate actions required for resolution.
• Investigate in-process and finished good non-conformances (NONCs) to identify root causes of production NCs.
• Investigate and write investigation summary reports for deviations across all functions, including Quality, Manufacturing, Validation, Engineering, Supply Chain, and Maintenance.
• Impartial investigator with the ability to conduct root cause analysis and utilize critical thinking when identifying and analyzing information accuracy and reliability.
• Assist with Corrective Action Preventive Action (CAPA) reports to identify root causes of issues to help assign appropriate corrective and preventative actions.
• Support coordination and investigations resulting from critical and adverse customer complaints. Help coordinate actions required for resolution.
• Ensure that investigation documentation moves through the approval process on a timely basis.
• Ensures quality assurance and regulatory compliance throughout the investigation process while adhering to applicable regulatory statute and standards.
• Stays updated on best practices, quality trends and regulatory requirements.
• Works alongside manufacturing, quality assurance/quality control, and other applicable departments to ensure that RCA is complete, and investigation is completed in a compliant manner.
• Tracks, monitors, and closes quality and manufacturing investigations.
• Identifies opportunities for continuous improvement.
• Prioritize to ensure commitments are met within the set time frame.
• Interface with all levels of the organization on behalf of QA Investigations
• Support the generation of Quality Metrics and KPI as applicable.
• Ensure spreadsheets/databases are current and available for investigation meetings and daily reporting.
• Participate in audits, customer, internal, external, as well as regulatory inspections.
• Handle special projects or assignments as directed by Quality Management team.
• Other duties as assigned.

PERFORMANCE MEASUREMENTS

• On time closure of CAPA root cause investigations and CAPA plans
• On time closure of Nonconformances
• Serve as Subject matter expert in quality assurance/quality control, operations, and manufacturing matters.

QUALIFICATIONS

EDUCATION/CERTIFICATION:

• Bachelor's degree with a scientific discipline

REQUIRED KNOWLEDGE:

• Working knowledge of QSR, ISO 9001:2000 and/or ISO 13485:2003, cGMP's.
• Thorough knowledge of the complaint process, 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, with emphasis in quality

SKILLS/ABILITIES:

• Excellent organizational and interpersonal skills
  Good analytical and problem-solving skills.
  Ability to interact professionally with all levels of staff and management and customers.
  Demonstrated leadership skills, self-starter.
  Excellent writing skills

WORKING CONDITIONS

• No hazardous or significantly unpleasant conditions.

ANNUAL SALARY

• $80,000 - $90,000 annually, plus bonus

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