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Compliance Specialist II

Integrated Resources, Inc

Northborough, MA

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JOB DETAILS
SALARY
$44–$45 Per Hour
SKILLS
Biotech and Pharmaceutical, Change Control, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Document Archiving, Documentation, Establish Priorities, External Audit, GMP (Good Manufacturing Practices), Internal Audit, Maintain Compliance, Management Strategy, Organizational Development/Management, Performance Analysis, Performance Metrics, Procedure Development, Product Lifecycle, Quality Assurance, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Management, Root Cause Analysis, SAP, Schedule Development, Strategic Planning, Support Documentation, Time Management
LOCATION
Northborough, MA
POSTED
30+ days ago
Job Title: Compliance Specialist II
Job Location: Northborough, MA (Fully Onsite)
Job Duration: 12 Months (possibility of extension)
Payrate: $44 - $45/ hr. on w2

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
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:
  • 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.

About the Company

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Integrated Resources, Inc