111 Coolidge Street South Plainfield, NJ 07080
With manager oversight, this role will support overall growth and compliance of the company by providing Quality Assurance support to Commercial Production, New Product Development and Launches, Process Improvements, Software Changes/Improvements, and Facility Changes/Improvements. Responsibilities will be Validation Support, Data Review for Submissions, Support to NPL /Core Teams to facilitate Quality Related Activities (New Suppliers, New Materials, Change Control’ s, Investigations/Non-Conformances, Quality by Design, etc.), and support to major site initiatives that require Quality activities. Additional responsibilities include QA review of formal investigations, planned deviation, and corrective and preventative action processes (CAPA), and complaint investigations. Role will also support Technical Transfers and Annual Product Reviews. Position requires influence skills and risked based decision making.
Essential Duties & Responsibilities:
Quality Review of Process Validation, Equipment/Instrument Qualification, Method Validations/Verifications, Computer System Validation Support, and other related protocol/document review.
Oversee and help manage the Deviation and CAPA systems. Review and provide initial approval of investigation reports submitted for completeness, errors, accuracy, offer solutions and implement preventative actions to avoid future occurrences of the problem. Offer solutions and ensure appropriate CAPA items have been implemented in timely manner to avoid future occurrences of the problem. Help manage the investigation of customer complaints and vendor corrective actions to help implement corrective or preventative action to help ensure product quality. Provide metrics and KPI’ s associated with deviations, CAPA, etc. Organize Quality Review Board on weekly basis and Material Review Board as needed.
Quality technical review of Changes Controls, QUMAS documents, and GMP Work Orders.
Quality support to New Product Launches and Core Team for related processes and Quality by Design.
Provide metrics and KPI’ s associated with deviations, CAPA, etc.
Organize Quality Review Board on weekly basis and Material Review Board as needed.
Support Annual Product Review Program.
QA oversight of technical transfer activities.
Drive continuous improvement projects to improve systems, compliance and efficiencies.
Quality support for major site initiatives that require Quality activities.
Additional responsibilities as assigned by manager
Four-year degree in a technical field, preferably in Life Sciences or Engineering.
Masters in a technical field, preferably in Life Sciences or Engineering.
2-5 years of experience in the pharmaceutical/regulated products industry, with a minimum of 3 years focus on reviewing protocols, methods, quality documents, and USP/NF.
Process/Method Validation experience
Quality Systems Experience
Change Control Experience
FDA Inspection Experience
Specialized or Technical Knowledge Licenses, Certifications needed:
Quality Engineering Training/Certificates
Lean/Six Sigma Knowledge
Strong computer skills, Microsoft Office Applications (Access, Excel and Word)
Analytical Method Validation
Computer Software Validation
Quality by Design
Statistical Knowledge/Sampling Plans
CAPA System/Root Cause Techniques
Supplier Quality Control
Company/Industry Related Knowledge:
Quality Management Systems
In-depth understanding, knowledge, and experience with FDA requirements for drugs and regulated products, and Quality Control/Quality Assurance.
In-depth understanding of Quality Control/Assurance.
Experience with application and use of Word, Excel, Visio and Project.
Experience with change control in a regulated environment.
Experience with document control/management in a regulated environment.
Fundamental knowledge of quality systems in regulated environments.
Writing for compliance; skilled at organizing information into a clear concise written form.
Customer focused, initiative, interdependent partnering.
Strong working knowledge of editing, proofreading, English spelling, grammar, and punctuation.
In-depth understanding of good documentation practices in a GMP environment.
Good organizational and planning skills. Good communication and presentation skills.
Ability to recommend and guide quality/compliance decisions that are data based and commensurate with risk.
Engage and maintain in a safe and clean work environment by following current good manufacturing practices (cGMP), housekeeping and safety audits (ie. 6S program), and standard operating procedures.