Senior Compliance Specialist Job Description
This role encompasses maintaining site compliance with operational requirements, inclusive of manufacturing, quality systems, quality control, and quality assurance. It involves administering site quality systems, including but not limited to; deviations, CAPA change control audits, customer complaints, quality risk management, reviewing and approval of documents relating to area functions.
* Maintain site's compliance with operations inclusive of manufacturing, quality systems, quality control, quality assurance, facilities maintenance, materials handling, and QA validation in accordance with mandated regulatory requirements and site expectations.
* Administrating and oversight of site quality systems including but not limited to; deviations CAPA change control audits customer complaints quality risk management reviewing and approval of documents relating to area functions.
* Monitoring and trending metrics associated with site quality systems participate in continuous improvement initiatives participating in regulatory and customer audits participating in quality risk assessments collaborating with functional departments to resolve issues and maintain compliance identifying gaps in systems and develop feasible plans for correction training of personnel on quality system processes.
This position may be suited for you if you:
* Have a proven track record of conducting on-site investigations and analysis.
* Are able to identify and address operational inefficiencies.
* Have implemented process improvements based on findings from direct workplace engagement.
* Can demonstrate respectful behavior at all times.
* Have basic working knowledge of Microsoft Suite (Word, Excel, PowerPoint).
To be considered for this position, you must hold a BS/BA in Engineering, Chemistry, or Life Sciences with 3+ years of relevant work experience in pharmaceutical or related industry.
We offer comprehensive benefits, which often include health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees.