Compliance Specialist

Job Title: Compliance Specialist IILocation: 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 requirementsEnsuring compliance with Good Manufacturing Practices (GMP) and other relevant regulationsPerform finished product inspections according to standards, specifications established timelinesPerform AQL inspections according to standards, specifications established timelinesTrend AQL failures according to standards, specifications established timelinesEnsuring 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 timelinesManage / perform annual inspection of retention samplesSupport creation of new material and product specificationsPerform document creation/revision, including periodic reviews, for department documentation according to established procedures and scheduled timelinesSupport department Quality Management System (Change Control, Deviations, CAPA)Support department documentation archival systemCollaborating closely with production to ensure quality standards are maintained throughout the product lifecycle; highly recommended to be located on the shopfloorManaging / escalating and resolving quality-related issues in a timely and effective mannerSupport the monitoring and analyzing of quality performance metrics, implementing corrective actions as neededSupport root cause analysis investigations for quality incidents and implementing preventive measuresSupport quality walkthroughsParticipating in internal and external audits and regulatory inspections providing support and documentation, as well as speaking as a subject matter expert in area of focusSupport risk management strategies to mitigate potential quality issuesFostering a culture of quality and continuous improvement across the organizationKey Roles- Request corrections when GMP rules are not respectedPrioritize quality and compliance objectivesRequest quality improvement initiatives and strategiesIdentify discrepancies and corrective/preventive actions that need to be takenEscalate to upper management any failure in GMP execution on shopfloorInform relevant stakeholders and team members of quality performance, corrective actions, findings, and preventive measuresAdvise on how to present a topic and answer specific questionsAdvise on risk management strategies and plansAdvise on initiatives to promote a quality-focused cultureMinimum 3 years of related experienceMinimum Education: Bachelors degreeMust 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