Quality Engineer; Consultant

Quality Engineer (6-Month Consultant - Onsite)

Job Category: Quality

Requisition Number: QUALI
002681

Showing 1 location

Gibbstown, NJ 08027, USA

• Company: Keystone Industries
  • Please visit our website  to learn more about Keystone Industries and career opportunities.
• Title:Quality Engineer/Consultant
• Schedule: Approximately 40 hours per week on average; actual hours may fluctuate, and some weeks may require fewer hours.
• Location: Gibbstown, NJ (08027)
  - on-site requirement; no relocation services available.
• Ideal Candidate: The ideal candidate will have 5-10 years of related experience. Experience with pharmaceutical and medical device production processes is required. Candidates should have experience with aseptic processing, including equipment qualification, process validation, and SOP authoring and implementation. Experience working in GMP-regulated manufacturing environments is strongly preferred.
• Salary/Pay Range (based on experience and qualifications): $75-$125 per hour, commensurate with experience and qualifications. Rate is flexible for highly qualified candidates.
• Consulting Engagement: We are seeking a consultant for an approximately six-month engagement to serve as a temporary backfill. This position will be structured as a 1099 independent contractor arrangement, and the selected consultant will be responsible for providing all required documentation and meeting applicable compliance requirements.

Essential Job Functions:

• Coordinate applicable steps to verify appropriate technology/design transfer for inter-site production and/or toll manufacturing.
• Evaluate new processes against regulatory, customer, and cGMP requirement. Influence process design by implementing process control techniques and risk-based decision making proactively, anticipating potential risks and recommending improvements.
• Develop validation strategies in accordance with regulations and customer requirements, applying judgment to resolve complex situations.
• Develop quality plans for components and products by applying statistical techniques and approved inspection methods.
• Identify and implement process improvements to enhance product quality, reduce variation, and increase operational efficiency.
• Develop quality plans for components and products by applying statistical techniques and approved inspection methods.
• Collaborate with process engineers to author, review, and approve specifications, equipment qualifications and process validation protocols and reports, and production documentation. Oversee and coordinate protocol execution as required.
• Evaluate engineering change controls, including but not limited to changes to specifications, qualified equipment, and validated processes.
• Act as quality lead for root cause analysis investigation and corrective/preventative action implementation.
• Assess process risk and author process risk assessments.
• Manage projects and participate in applicable project core team(s) and extended team(s).
• Interface regularly with external suppliers and customers, supply chain, quality control, quality assurance, production, engineering, analytical and R&D personnel.
• Works closely with production in a cleanroom environment to establish an understanding of production equipment and processes
• Provide sound and timely decision-making utilizing statistical problem-solving tools.
• Support notified body, customer, supplier, and subcontractor audits and inspections.
• Keep management informed on project status and significant quality issues in a manner commensurate with the potential impact of the issue.
• Support future Engineering and Quality initiatives.
• Perform research as needed to support other job functions and responsibilities.
• Perform additional duties/tasks as needed or requested by…