The Role
Supports pharmaceutical manufacturing and quality systems, including change controls, deviation investigations, CAPAs, risk assessments, process validation, training, batch records, procedures, and process improvements. Owns manufacturing quality records, uses TrackWise and SAP, supports inspections, campaign readiness, troubleshooting, and cross-functional implementation of process, automation, equipment, and documentation changes in a cGMP environment.
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 Engineering, Life Sciences, Chemistry, Microbiology, or a related scientific discipline.
- Experience in the pharmaceutical, biotechnology, or medical device industry within a cGMP-regulated environment.
- Strong knowledge and hands-on experience with Change Control processes and quality systems.
- Experience serving as a Quality Record Owner or managing supplier-related Change Control quality records.
- Proficiency in TrackWise for creating, managing, and closing quality records.
- Working knowledge and experience with SAP for supplier-related quality documentation and record management.
- Demonstrated critical-thinking and risk assessment skills to evaluate supplier-related quality records and drive compliant decisions.
- Experience leading and facilitating cross-functional meetings to ensure timely execution and closure of Change Control records.
- Strong organizational, communication, and collaboration skills with the ability to work effectively across multiple stakeholders.
- Ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.
- Proficiency in written and verbal communication in English; bilingual English/Spanish is preferred.
- Administrative Shift
Skills Required
- Bachelor’s degree in Engineering, Life Sciences, Chemistry, Microbiology, or a related scientific discipline.
- Experience in the pharmaceutical, biotechnology, or medical device industry within a cGMP-regulated environment.
- Strong knowledge and hands-on experience with change control processes and quality systems.
- Experience serving as a Quality Record Owner or managing supplier-related Change Control quality records.
- Proficiency in TrackWise for creating, managing, and closing quality records.
- Working knowledge and experience with SAP for supplier-related quality documentation and record management.
- Critical-thinking and risk assessment skills for evaluating supplier-related quality records and driving compliant decisions.
- Experience leading and facilitating cross-functional meetings to ensure timely execution and closure of Change Control records.
- Strong organizational, communication, and collaboration skills.
- Ability to manage multiple priorities, meet deadlines, and work independently with minimal supervision.
- Proficiency in written and verbal English communication.
- Bilingual English/Spanish communication skills.
- Availability for an administrative shift.
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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
