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Job Requirements of Compliance Specialist II- 1st Shift:
-
Employment Type:
Contractor
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Location:
Northborough, MA (Onsite)
Do you meet the requirements for this job?
Compliance Specialist II- 1st Shift
Careers Integrated Resources Inc
Northborough, MA (Onsite)
Contractor
Title: Compliance Specialist II- 1st Shift
Location: Northborough, MA (Fully Onsite)
Duration: 12 Months+ Possible Extension
Manager Notes:
Must have Skills:
Main Accountabilities:
Location: Northborough, MA (Fully Onsite)
Duration: 12 Months+ Possible Extension
Manager Notes:
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)
- Change Control, Deviations, CAPA (strongly preferred)
- SAP, Veeva
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
- Minimum Education: Bachelors degree
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