Senior Quality Compliance/Validation Engineer
Sterling Life Sciences - Newark, NJ
Partial Job Description
1) Lead and participate in a hands-on manner activities related to the design, implementation and maintenance of quality assurance processes and systems, including process controls, initiation, analysis and auditing of qualification protocols, standard procedures, quality reports, compliance and business improvements in support the Company's Quality Policy
2) Develop, review and approve facility, system and equipment validation documentation, equipment qualification packages, facility utility systems, automation systems, computerized systems and manufacturing process documentation, including equipment maintenance programs
3) Conduct critical assessments and audits of all processes and equipment to identify areas of improvement
4) Initiate and ensure quality complaints are fully investigated, documented and reported in compliance with SOP's
5) Implement and manage deviation and revalidation programs
6) Perform documented risk assessments and develop remediation plans in consultation with management, customers and regulatory bodies
7) Oversee quality assurance review and approval of Validation, Technical Services, Engineering and Quality Control protocols, procedures, test plans and summary reports
8) Generate Functional, Design and Operator Requirement specifications, Standard Operating Procedures and applicable work instructions
9) Lead and mentor QA technician staff in a supervisory capacity
10) Oversee the company?s Facility Safety Compliance program
11) Manage the company?s sterility processes, including clean room and facility activities
12) Participate in quality and regulatory audits, defend site validation efforts during outside audits
13) Serve as lead auditor for internal and supplier audits
14) Participate as a key member of the company Compliance Committee
15) Participate in formal management review
16) Ensure evaluation and dissemination of company quality standards, initiatives and guidelines
17) Serve as design control team member
18) Oversee technical and quality issues encountered during mitigation activities and resolve related issues
19) Maintain quality assurance programs, policies, processes and procedures to ensure that performance and quality of products conform to established standards

Qualifications / Skills Required
1) University Degree is required; preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply
2) Appropriate full-time work experience is mandatory. No students or fresh graduates please

CareerBuilder - 17 months ago - save job - block