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JP Techno Parkposted 3 months ago
$60,000 - $80,000/Yr
Full-time - Mid Level
Fall River, MA
About the position
The QA Manufacturing Inspector plays a critical role in ensuring product quality throughout the manufacturing process in a pharmaceutical environment. This position focuses on compliance with established specifications, Current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs). The inspector is responsible for monitoring, inspecting, and documenting quality assurance processes, ensuring that all products meet the required quality standards before reaching the market.
Responsibilities
- Perform in-process testing (e.g., weight, thickness, hardness, disintegration, friability) as per manufacturing batch record instructions.
- Conduct room and equipment checks prior to each stage of manufacturing by following detailed written procedures.
- Review batch manufacturing/packaging records and approve manufacturing/engineering validation and qualification documents.
- Provide daily/weekly updates to shop floor and management regarding quality highlights and concerns.
- Monitor facility and product environmental conditions and ensure compliance with cGMP requirements.
- Inspect in-process and finished product samples for Quality Control (QC) Lab and document results.
- Maintain records of standard weights and verify balances daily.
- Ensure proper isolation and accountability of rejected material during batch processing.
- Identify and report non-conformances and discrepancies to management.
- Complete and maintain detailed and accurate documentation in alignment with SOPs.
Requirements
- Bachelor's degree in pharmaceutical manufacturing, industrial management, or related field of study from an accredited college/university is preferred.
- 5 years experience in quality assurance in a cGMP pharmaceutical manufacturing operation and work environment.
- Strong knowledge of cGMP requirements and quality assurance protocols.
- Proficiency in computer applications such as Microsoft Office, SAP, and other business tools.
- Excellent organizational, verbal, written, and presentation communication skills.
Nice-to-haves
- Experience in MDI or combination products is preferred.
