Job Title: Quality Assurance and Regulatory Consultant
Location: Paramus, NJ
Duration: 5 Months (Potential for Extension or Conversion)
Job Type: Contract
Work Type: Hybrid (Preferred Local to Paramus, NJ)
Pay Rate: $100-$125/hr
Overview:
Our Client is seeking an experienced Quality Assurance and Regulatory Consultant with expertise in solid-dose pharmaceutical manufacturing and packaging. The consultant will analyze customer complaints regarding broken tablets and low-fill bottle counts, review processes, and provide actionable recommendations for improvement. The role is crucial in enhancing both manufacturing and packaging standards, addressing quality issues, and improving customer satisfaction
Key Responsibilities:
Complaint Analysis:
- Conduct a detailed review of customer complaints focusing on "low fill" issues and "broken tablets.
- Categorize and prioritize complaints by frequency and severity since the end of 2022 for low-fill complaints and since mid-2023 for broken tablets.
Process Evaluation:
- Perform a thorough analysis of both the packaging and manufacturing processes to identify root causes.
- Recommend improvements to prevent recurrence of these issues, specifically targeting the low-fill issue in 200mg/30ct bottles and broken tablets across all products.
- Review existing packaging processes and suggest methods to cull broken tablets before bottling.
Recommendations and Reporting:
- Provide detailed recommendations for process improvements to both packaging and manufacturing teams.
- Work collaboratively with the SKLSI team to implement process enhancements.
- Prepare and submit weekly progress reports and time logs for work justification.
Documentation and Compliance:
- Review batch records, complaints, and other documentation provided through SharePoint.
- Comply with all internal policies, including access through "Compliance Wire" and Veeva database for record-keeping and data retrieval.
- Ensure recommendations comply with regulatory and quality standards in pharmaceutical manufacturing.
Communication:
- Maintain close communication with the SKLSI management team to ensure resources and support are available for timely project completion.
- Engage with both in-house QA and CPM personnel for knowledge sharing and collaborative improvements.
Tools and Resources:
- Utilize company-provided tools, including a laptop and access to SharePoint, email, and relevant documentation.
Skills & Qualifications:
Experience:
- Proven expertise in "Pharmaceutical Manufacturing” and "Packaging” with a strong understanding of solid-dose production (particularly bottle filling).
- Background in “Quality Assurance” with specific experience in handling quality-related issues in bulk manufacturing and packaging.
Process Improvement:
- Demonstrated experience in reviewing manufacturing/packaging processes and implementing changes to enhance quality and compliance.
- Familiarity with analyzing data and customer complaints to drive actionable improvements.
Regulatory Knowledge:
- Strong understanding of pharmaceutical regulatory standards and GMP guidelines.
- Ability to ensure all recommendations align with relevant FDA, EU, and global regulatory standards.
Technical Proficiency:
- Proficiency in working with quality databases and systems, such as Veeva and SharePoint.
- Experience with digital training platforms such as "Compliance Wire.”
Consulting Experience:
- Proven track record of providing consulting services to pharmaceutical companies with the ability to work independently or as part of a team.
Travel:
- Reimbursable travel may be required based on project demands and client needs.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.
