Compliance Specialist

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