Compliance Specialist II (Manufacturing/Quality)

Immediate need for a talented Compliance Specialist II (Manufacturing/Quality). This is a 12 Months contract  opportunity with long-term potential and is located in Northborough, MA , USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-08294

Pay Range: $ 33-$43  /hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
 
Key Responsibilities: 

• Support department Quality Management System (Change Control, Deviations, CAPA)
• 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
• 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

Key Requirements and Technology Experience: 

• Key skills: - Experience with inspecting finished goods and product
• Quality Shop floor experience
• Fully onsite position Possibility of extension Open to candidates willing to relocate at their own expense
• Top candidates, references will be requested Free parking onsite
• 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)
• Change Control, Deviations, CAPA (strongly preferred) • SAP, Veeva
• Minimum 3 years of related experience
• Minimum Education: Bachelors degree

Our client is a leading Pharmaceuticals industry  , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

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