QA Compliance Specialist

• Develop, implement, support and manage quality programs ensuring that program deliveries  are meet or exceed expectations
• Build successful relationships within account’s personnel and other client personnel to promote confidence, forward planning, and best practices
• Provide management and leadership for the design, development, implementation and sustainability of quality and compliance programs
• Collaborate with site’s team and proactively share and reapply all learnings, successes, and best practices
• Responsible for supporting quality programs (i.e. Non-Conformance Investigations, CAPAs, Training Compliance, Vendor Qualifications, Quality Agreements, Audits, Self-Assessments, Document Management,
• Change Control, etc.) that ensures that the work conducted by the Facilities team, and its subcontractors, perform the work in full accordance with SOP’s, applicable industry regulations, current practices and contractual requirements.
• Perform/support audits and prepare documents, and training materials for use by site staff in the performance of their work.
• Expected to interface with the client’s quality personnel to ensure that all the client’s requirements are followed, and that the work performed by the team is documented and recorded in the proper fashion.
• Manage and report on Quality and Compliance critical & key performance measurements.  Develops and submit status reports related to the Quality Program
• Effectively lead staff by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement.
• Provides management/information to vendors, account staff and service providers as required to ensure that quality assurance expectations and changes to industry regulations are communicated and followed.
• Any other duties and tasks as deemed necessar

• Bachelor's degree or equivalent in a relevant field such as quality management, business administration, or a related discipline.
• 3 years of experience in similar roles.
• Strong background in technical documentation.
• Ability to investigate, recognize and diagnose trends and patterns.
• Experience with Root Cause Analysis and tools.
• General understanding of cGMP’s as they relate to the performance of maintenance and repairs to facilities, utilities and equipment utilized for the manufacturing of drug products.
• Experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity.
• Understanding of FDA regulations including 210 CFR part 210 and 211.
• Strong commitment to quality assurance, and a willingness to help develop a quality first culture on the Site.
• Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems.
• Communicate effectively with technical, quality assurance and other personnel.
• Proficient in Microsoft Office Suite programs Word, Excel and QMS System such as COMET.
  

This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship.

If this job description resonates with you, we encourage you to apply, even if you don’t meet all the requirements.  We’re interested in getting to know you and what you bring to the table!