The Role
Lead change control, support deviation investigations and CAPA, conduct risk and microbial impact assessments, oversee commercial campaign readiness, develop training and SOPs, provide on-floor troubleshooting and testing (functional/water/process challenge), improve MBRs and processes, and act as SME for technical problem-solving and continuous improvement in GMP biomanufacturing.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Qualifications:
Responsibilities:
- Lead and manage change control activities related to manufacturing process changes, ensuring compliance with quality and regulatory requirements.
- Support major and trend deviation investigations throughout the full investigation lifecycle, including Root Cause Analysis (RCA), identification and implementation of Corrective and Preventive Actions (CAPA), authoring investigation reports, and presenting findings during regulatory inspections.
- Participate in Risk Assessment activities and perform microbial impact assessments to support manufacturing operations and process changes.
- Lead commercial campaign readiness activities while effectively collaborating and communicating with cross-functional teams, including Manufacturing, Quality, Engineering, and Process Development.
- Develop technical and scientific training materials and provide training support to manufacturing and operational personnel as needed.
- Provide on-floor manufacturing support and troubleshooting assistance during commercial operations and process execution.
- Design, coordinate, and support the execution of functional testing, water testing, and process challenge runs associated with major process changes, equipment modifications, and campaign readiness activities. Generate technical protocols and related documentation as required.
- Support the creation, revision, and continuous improvement of Master Batch Records (MBRs).
- Assess and support process, automation, and equipment modifications, including implementation of special projects and continuous improvement initiatives.
- Author, revise, review, and approve Standard Operating Procedures (SOPs) and manufacturing procedures to ensure alignment with current operations and regulatory standards.
- Serve as document owner when applicable.
- Monitor and evaluate process performance data to identify trends, assess process effectiveness, and implement process improvement solutions.
- Perform CAPA applicability assessments for requests received from other manufacturing sites or plants.
- Conduct assessments related to new or modified Bills of Materials (BOMs).
- Serve as a subject matter expert (SME) in at least one technical area, providing leadership in methodology selection, technical problem-solving, and best practices implementation.
Qualifications:
- Bachelor’s degree in Engineering
- Strong hands-on experience in bioprocessing unit operations within a regulated manufacturing environment.
- Solid knowledge of Root Cause Analysis (RCA) methodologies, including Fishbone Diagram, Six Boxes, 5 Whys, and Kepner-Tregoe problem-solving techniques.
- Familiarity with Lean Manufacturing principles and continuous improvement methodologies.
- Demonstrated ability to effectively communicate and collaborate with technical and management teams across Manufacturing, Process Development, Engineering, and Quality organizations.
- Proficient in Good Documentation Practices (GDP) within a GMP-regulated environment.
- Experience working with systems and platforms such as TrackWise, Spotfire, CDOCS, and process monitoring systems.
- Strong technical writing, presentation, and documentation skills.
- Excellent verbal and written communication skills in both English and Spanish.
- Ability to manage multiple priorities in a fast-paced manufacturing environment while maintaining compliance and operational excellence.
- 8 hrs. shift (1st Shift)
Skills Required
- Bachelor's degree in Engineering
- Hands-on experience in bioprocessing unit operations within a regulated manufacturing environment
- Solid knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Whys, Kepner-Tregoe)
- Familiarity with Lean Manufacturing and continuous improvement methodologies
- Proficient in Good Documentation Practices (GDP) within a GMP-regulated environment
- Experience with TrackWise, Spotfire, CDOCS, and process monitoring systems
- Strong technical writing, presentation, and documentation skills
- Excellent verbal and written communication skills in English and Spanish
- Ability to manage multiple priorities in a fast-paced manufacturing environment
- Availability to work 8-hour 1st shift
- Serve as subject matter expert in at least one technical area
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
