The Role
Support manufacturing and quality systems for bioprocess operations, owning change controls, investigations, CAPA assessments, and process improvements. Lead campaign readiness, generate protocols and training, assist MBR creation, perform risk and microbial assessments, and support troubleshooting and technical documentation in regulated environments.
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 to a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities:
Responsibilities:
- Support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
- Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
- May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
- Own change controls for manufacturing process changes
- Support major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
- Support Risk Assessments exercises and Microbial assessment evaluations.
- Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
- Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
- Provide commercial support when needed and assist on the floor troubleshooting.
- Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
- Assist and provide guidance during MBR (Master Batch Record) creation/revisions.
- Perform assessment to support process, automation, or equipment modification or implementation of special projects
- Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
- Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
- Complete assessments for CAPA applicability requests from other plants/sites
- Complete assessment for new or changes in BOM's (Bill of Materials)
- Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
- In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
- Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, Fishbone, 5 Why’s, Kepner Tregoe)
- Previous experience in major/trend deviation investigations throughout the whole lifecycle including Root Cause Analysis investigation, determination of Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
- Familiar with Lean Manufacturing Practices
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
- Proficiency in GDP (Good Documentation Practices) on a regulated environment
- Knowledge in systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
- Strong Technical Writing/presentation abilities, and excellent written/verbal communication skills in English and Spanish
Skills Required
- Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering
- In-depth experience of bio-processing unit operations (Cell Culture, Drug Substance Purification)
- Knowledge in Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why's, Kepner Tregoe)
- Experience in major/trend deviation investigations across lifecycle, CAPA determination, and authoring process investigation reports
- Familiarity with Lean Manufacturing practices
- Proficiency in Good Documentation Practices (GDP) in a regulated environment
- Knowledge of systems: Trackwise, Spotfire, CDOCS, and process monitoring platforms
- Strong technical writing and presentation abilities; excellent written and verbal communication in English and Spanish
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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
