IR
Compliance Specialist II
Integrated Resources, Inc
🇺🇸 United States
On-site
6 months ago
- GMP
- CAPA
- Risk Management
- SAP
- Veeva
6 months ago
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
- 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.
- Bachelors degree.
- Quality Shop floor experience, quality assurance review experience.
- Experience with inspecting finished goods and product.
- Previous pharma and biotech experience / GMP (strongly preferred).
- Change Control, Deviations, CAPA (strongly preferred).
- SAP, Veeva.
Compliance Specialist II · Integrated Resources, Inc