Job Title: Compliance Specialist II
Location: Northborough, MA(01532)
Duration: 12 Months(Possibility of extension)
Shift: 1st Work Schedule: M-F 8am-5pm (OT possible and weekends if needed)
Job Description:
Main Accountabilities- Ensuring that activities within scope 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
Key Roles- 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
Minimum Education: Bachelors degree
Must have Skills:
• Bachelors degree (Masters and PHD's will be accepted)
• 3 Year experience in related role (more experience the better)
• Quality Shop floor experience, quality assurance review experience
• Experience with inspecting finished goods and product
• Previous pharma and biotech experience / GMP (strongly preferred)
Nice to have
• Change Control, Deviations, CAPA (strongly preferred)
• SAP, Veeva