Compliance Specialist II

Job Description

Main Accountabilities:

• Ensuring that activities within Product are conducted in compliance with applicable regulatory requirements.
• Ensuring compliance with Good Manufacturing Practices (GMP) and other relevant regulations
• Perform finished product inspections according to standards, specifications established timelines
• Perform AQL inspections according to standards, specifications established timelines
• Trend AQL failures according to standards, specifications established timelines
• Ensuring all batch release activities comply with Good Manufacturing Practices (GMP)
• Manage the sampling, storing, monitoring and maintenance of finished product retention samples according to standards, specifications and established procedures and timelines
• Manage / perform annual inspection of retention samples
• Support creation of new material and product specifications
• Perform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelines
• Support department Quality Management System (Change Control, Deviations, CAPA)
• Support department documentation archival system
• Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloor
• Managing / escalating and resolving quality-related issues in a timely and effective manner
• Support the monitoring and analyzing of quality performance metrics, implementing corrective actions as needed
• Support root cause analysis investigations for quality incidents and implementing preventive measures
  Support quality walkthroughs.
• Participating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focus
• Support risk management strategies to mitigate potential quality issues
• Fostering a culture of quality and continuous improvement across the organization.

Responsibilities:

• Request corrections when GMP rules are not respected.
• Prioritize quality and compliance objectives.
• Request quality improvement initiatives and strategies.
• Identify discrepancies and corrective/preventive actions that need to be taken.
• Escalate to upper management any failure in GMP execution on shopfloor.
• Inform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measures.
• Advise on how to present a topic and answer specific questions.
• Advise on risk management strategies and plans.
• Advise on initiatives to promote a quality-focused culture.
• Minimum 3 years of related experience.

Education:

• Bachelors degree.

Must have Skills:

• Quality Shop floor experience, quality assurance review experience.
• Experience with inspecting finished goods and product.
• Previous pharma and biotech experience / GMP.

Nice to have:

• Change Control, Deviations, CAPA (strongly preferred).
• SAP, Veeva.