Overview

The Sr. Quality Assurance Engineer supports compliance with applicable regulatory requirements by maintaining an effective quality management system and implementing continuous improvements. This position is responsible for activities ranging from product development through commercialization. This is a hands-on role where the Sr. Quality Engineer will apply diversified knowledge of engineering, quality principles and practices for pharmaceutical and combination products. This position requires technical expertise in Aseptic Techniques. The Senior Quality Engineer is responsible for performing a quality role for the aseptic manufacturing, quality systems and compliance in accordance with cGMP, related company SOP’s, federal laws, guidelines, and regulations during the receipt, storage, manufacture, and distribution of products.

Requirements

  • Maintain and improve Quality System in accordance with FDA Regulations and ISO 13485 requirements
  • Provide hands-on direction for aseptic process and cGMP manufacturing activities
  • Support quality assurance activities, including, but not limited to: Risk Management (FMEAs, HA), internal and external audits, NCMRs and CAPAs
  • Collaborate with cross functional teams Manufacturing, Engineering, Facilities to ensure adherence to cGMP guidelines
  • Conduct investigations for issues associated with audits, lot history records and complaints. Approve manufacturing and testing deviations and investigations
  • Evaluation and support for implementation of new processes, lead continuous improvement of aseptic / sterile processes
  • Lead and support qualification and validation of cGMP equipment, facilities, utility systems, analytical test methods, cleaning and manufacturing processes. These duties will include, but are not limited to: the implementation and documentation of these validations and their lifecycle management in compliance with FDA and EU regulations
  • Manage the deviation system, perform QA assessment of deviations and ensure that all assessments are completed, review and approve deviation reports
  • Assist in the review and approval of lot history records and test records
  • Conduct audits at CMO, testing operations and internal audits
  • Assist in development, review and approval of process and equipment validation/qualifications (IQ, OQ, PQ), summary reports, ensure qualifications are conducted in accordance with the Validation Master Plan
  • Investigate product quality problems and determine root cause, gather and analyze data, and implement corrective actions to reduce or eliminate cause
  • Lead the resolution of quality issues related to non-conformance reports and CAPAs
  • Develop and initiate sampling procedures and statistical process control methods
  • Address systemic quality issues with suppliers or internal groups
  • Evaluate product changes for qualification and validation requirements and assist in change implementations
  • Other duties/ activities may be necessary to support departmental or company goals

Education and Job Experience

  • Bachelor’s degree or higher in Chemistry, Biology, or equivalent scientific discipline
  • A minimum of 7 years quality assurance/engineering experience within the pharmaceutical or biopharmaceutical industry is required
  • cGMP experience is required
  • Experience with performing utility qualification activities for vaporized hydrogen peroxide (VHP) system is preferred Excellent communication skills both oral and written
  • Understands and applies comprehensive knowledge of quality and GMP principles. Maintains current understanding of global GMP regulations
  • Experience with FDA Regulations (21 CFR part 820, part 210 and part 211) and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience regarding root cause analysis and statistical techniques (such as Cause and Effect Analysis, Fishbone Diagram, 5 Whys, Six Sigma processes)

Skills and Specifications

  • Ability to motivate and influence people
  • Must possess the ability to handle multiple tasks with high attention to detail Organizing, planning, and problem-solving skills
  • Good interpersonal and communication skills
  • Ability to work as a part of a team
  • Ability to review, analyze, summarize, and interpret data; draw conclusions and make appropriate recommendations and decisions; write reports
  • Ability to create and provide training
  • Good statistical and numerical ability