The Role
Supports pharmaceutical manufacturing and quality systems, including process validation, change controls, deviations, CAPAs, risk assessments, procedure ownership, batch record alignment, training, regulatory inspections, new product introductions, and process improvement. The role provides technical troubleshooting on the manufacturing floor, supports campaign readiness and equipment or process modifications, and acts as a recognized specialist in at least one manufacturing area.
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:
Qualifications:
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.
Qualifications:
- Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
- Experience initiating, revising, approving, and maintaining manufacturing procedures, serving as the document owner and ensuring procedures accurately reflect current operations.
- Ability to assess process performance through floor observations and performance data analysis, and to identify, plan, and implement process improvement opportunities.
- Experience developing training materials and providing training on scientific and technical aspects of manufacturing processes.
- Knowledge of cGMP requirements and other applicable regulations, with the ability to ensure processes and procedures remain compliant.
- Ability to identify, assess, and mitigate process risks to ensure product safety, purity, quality, and manufacturing efficiency.
- Experience maintaining and ensuring alignment of Electronic Batch Records (EBRs) with current manufacturing processes and supporting related training activities.
- Experience supporting the development and implementation of process validation protocols and reports.
- Ability to participate in regulatory inspections and provide technical support as required.
- Experience participating in New Product Introduction (NPI) activities, including assessment of documentation, materials, training, and equipment modification requirements.
- Ability to assess, prioritize, support, and provide project management assistance for process and equipment modification projects.
- Experience owning and managing Change Controls, ensuring timely implementation within established timelines and goals.
- Ability to support Manufacturing Change Owners in the preparation and review of CCRB packages impacting manufacturing processes.
- Experience participating in non-commercial manufacturing runs to support process data collection, analysis, and evaluation.
- Ability to participate in the assessment and implementation of special projects, process improvement initiatives, and other manufacturing-related activities.
- Shift: Admin 8am-5pm | OT may be required based on business needs.
Skills Required
- Bachelor's degree in Life Sciences, Biology, Chemistry, and/or Engineering.
- Experience initiating, revising, approving, and maintaining manufacturing procedures as document owner.
- Ability to assess process performance using floor observations and performance data analysis.
- Experience identifying, planning, and implementing process improvement opportunities.
- Experience developing training materials and providing scientific or technical manufacturing training.
- Knowledge of cGMP requirements and applicable regulations.
- Ability to identify, assess, and mitigate process risks related to product safety, purity, quality, and efficiency.
- Experience maintaining Electronic Batch Records and aligning them with current manufacturing processes.
- Experience supporting process validation protocols and reports.
- Ability to participate in regulatory inspections and provide technical support.
- Experience participating in New Product Introduction activities.
- Ability to support project management for process and equipment modification projects.
- Experience owning and managing Change Controls.
- Ability to support Manufacturing Change Owners with CCRB packages affecting manufacturing processes.
- Experience participating in non-commercial manufacturing runs for process data collection and evaluation.
- Ability to participate in special projects and manufacturing process improvement initiatives.
- Availability for an administrative shift from 8 a.m. to 5 p.m., with overtime as needed.
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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
