This position supports the Quality Assurance program by executing a broad range of responsibilities with minimal supervision. The role is ideal for candidates with strong experience in manufacturing quality systems, validation, and regulatory compliance.
Key Responsibilities:
- Review and approve Master Production Records (MPs)
- Approve process validation protocols and reports
- Participate in incident triage and approve planned incidents
- Approve Environmental Characterization reports and sanitary utility system releases
- Represent QA on New Product Introduction (NPI) teams
- Lead investigations and site audits
- Own and manage site quality program procedures
- Serve as designee for QA Manager on local Change Control Review Board (CCRB)
- Review risk assessments and support automation, facilities, and environmental programs
- Review and approve work orders and EMS/BMS alarms
- Approve non-conformance investigations and CAPA records
- Approve change controls and authorize lot disposition for shipment
Skills:
- Strong project management and organizational skills
- Ability to lead cross-functional teams and influence stakeholders
- Expertise in QA, QAL, manufacturing, validation, and process development
- Skilled in regulatory interaction and compliance evaluation
- Advanced data trending and analysis
- Proficient in MS Office (Word, Excel, PowerPoint, databases)
- Excellent communication, facilitation, and presentation abilities
- Ability to work independently and collaborate across all levels
Requirements
- Doctorate (PhD)
- Master’s degree + 2 years of directly related experience
- Bachelor’s degree + 4 years of directly related experience
- Associate’s degree + 8 years of directly related experience
- High School Diploma/GED + 10 years of directly related experience
Preferred Qualifications:
- Experience with New Product Introduction (NPI)
- Familiarity with Change Control processes
- Exposure to Factory Acceptance Testing (FATs)
- Hands-on experience with Validation and Process Performance Qualification (PPQ)
Benefits
- 10- months contract with possible extension
- Administrative Shift
Top Skills
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results.
Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields.
We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions.
BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
