Senior Compliance Analyst
JLL - Manati, PR
Position Summary:
The Quality Compliance Specialist should have a strong background in quality assurance requirements for a Pharmaceutical Manufacturing facility from a facilities and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facility Maintenance team, and its subcontractors, perform the work in accordance and compliance with JLL, BMS Policies and procedures, and FDA cGMP regulations. The specialist for this role should have a solid understanding of cGMP’s as they relate to the performance of maintenance and repairs to facilities and utilities utilized for the manufacturing of drug products. A background in pharmaceuticals is highly desired. The specialist should be able to prepare/revise/audit SOP’s, change control documentation, investigations, CAPA’s and training materials used by the facilities maintenance team in the performance of their work. In addition, this position is expected to interface with the client’s quality control personnel to ensure that applicable BMS SOP’s are followed, and that the work performed by the team is documented and recorded in the proper fashion.
The Quality Specialist will be responsible for executing JLL’s Quality Compliance program for a cGMP manufacturing facility. This includes training verification, facility self-assessment, documentation, and vendor/suppliers audits. Specialist should have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.
Requires understanding of FDA regulations including 210 CFR part 210 and 211. The Quality Specialist must have a strong commitment to quality assurance, and a willingness to support the quality first culture on the Site. Must be self-motivated, detail oriented, comfortable working in a dynamic team environment with minimal supervision. Specialist must have a Knowledge of Quality Engineering techniques, CMMS systems, Calibration, and Quality Management Systems. Working knowledge of computer applications including MS Word, Excel and Power Point is a must. He/she should possess good oral and written communication skills in English, including the ability to communicate to all levels of management and interface with a diverse customer base, including technical and non-technical personnel. Proven record of excellent internal and external customer service with a minimum of 4-7 years of experience in quality engineering, facilities maintenance, and production/facility operations or equivalent is desirable.
Roles and Responsibilities include, but are not limited to:
- Reads and comprehend the applicable Service Level Agreements, helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys.
- Provides facility specific quality assurance assistance to the project management team as needed or requested.
- Ensures appropriate follow up with customers.
- Seeks to continuously improve quality processes, systems and overall client satisfaction.
- Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.
- Perform facilities, utilities and maintenance related Non-Conformance Investigations and CAPAs.
- Conduct self-audits of areas and 3rd Party Vendors within JLL’s scope of work.
- Training coordination, follow-ups and preparations.
- Support the client in preparing for Internal and External audits.
- Development and implementation of risk assessment programs.
- Execute additional job duties as requests, analysis and reporting
Start a lasting career with JLL today!
Total Rewards reflects JLL’s investment in employees’ needs and preferences in Career, Recognition, Well-being, Benefits and Pay. We offer a competitive salary and benefits package. To be considered, please visit our Web site at www.us.am.joneslanglasalle.com/UnitedStates/EN-US/Pages/Careers.aspx to apply online. All resumes MUST BE submitted via our web site. Please reference Job 54880BR
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Posted: 30+ days ago
