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:
- Approve process validation protocols and reports for mfg. processes.
- Represent Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Bachelor's degree in related area
- 6 years of directly related experience
- Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
- Demonstrated ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
Skills Required
- Bachelor's degree in a related area
- Six years of directly related experience
- Experience with commissioning and qualification
- Experience with equipment validation
- Experience with QRAES
- Experience with Kneat
- Experience with Good Documentation Practices
- Experience with change controls
- Experience with SOPs
- Project management skills
- Strong organizational skills and ability to complete assignments
- Knowledge of manufacturing, distribution, QA, QAL, validation, and process development
- Ability to interact with regulatory agencies
- Word processing, presentation, database, and spreadsheet application skills
- Strong written and oral communication, facilitation, and presentation skills
- Advanced data trending and evaluation skills
- Ability to evaluate compliance issues
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
