On Site Personnel ยท 1 month ago
Quality Management Specialist
Bucks County, PA
Full-time
Onsite
New Grad, Entry LevelOn Site Personnel is an equal opportunity employer committed to hiring a diverse workforce in an inclusive culture environment. The Quality Management Systems Associate ensures quality and compliance of the facility with applicable regulatory requirements, conducting audits, maintaining quality databases, and providing training as needed.
Human ResourcesOutsourcingRecruitingStaffing Agency
Responsibilities
Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices including but not limited to sample management and accountability, data integrity (manufacturing, calibration and maintenance logbooks, batch record documentation) and adherence with applicable safety requirements. Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness
Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations
Review SOPs, Specifications, Batch Record Documentation
Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council
Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements
Qualification
Required
Ensures quality and compliance of the facility with applicable regulatory requirements
Reviewing documents and data
Conducting systems or process-focused audits and inspections
Consulting on quality and compliance issues
Maintaining quality databases
Performing trend analyses and reporting metrics where required
Performing quality/compliance training as needed
Providing support during regulatory inspections
Assisting with the development of SOPs, specifications, and other quality document control activities as needed
Conduct routine walk-throughs of manufacturing areas for adherence with SOPs and good documentation practices
Review documentation, results and reports from raw material and finished product analysis for accuracy and completeness
Perform regularly scheduled, formalized internal audits of manufacturing areas for adherence with SOPs, cGMPs, FDA, OSHA, EPA and DEA regulations
Review SOPs, Specifications, Batch Record Documentation
Maintain KPIs related to manufacturing accuracy and conformance with SOPs, regulations and Guidelines and present to the Quality Council
Review and maintain Quality Management Records (Change control, Deviation, CAPA, Root cause Investigations, Market complaints, Product recall, OOS and Outliers) to ensure compliance with procedures and assurance of due date requirements
Company
On Site Personnel
On Site Personnel provides staffing solutions coupled with recruiting, training, and human resource outsourcing services.
Founded in 1991
1001-5000 employees
H1B Sponsorship
On Site Personnel has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
Funding
Current Stage
Late StageCompany data provided by crunchbase