Cipla - Fall River, MA

posted 3 months ago

Full-time - Mid Level
Fall River, MA
Merchant Wholesalers, Nondurable Goods

About the position

The Quality Assurance (QA) Analyst I position at InvaGen Pharmaceuticals, a subsidiary of Cipla, is a critical role that requires a strong background in analytical chemistry and laboratory practices. This individual contributor role is based in Fall River, Massachusetts, and reports directly to the Quality Assurance Manager. The primary purpose of this position is to ensure compliance with established protocols and regulations within the pharmaceutical manufacturing environment. The QA Analyst will be responsible for confirming the compliance of method validations, monitoring adherence to current Good Laboratory Practices (cGLP), and verifying standard operating procedures (SOPs) and test procedures. In this role, the QA Analyst will coordinate with the Regulatory Affairs and Analytical Laboratory Teams to ensure timely submission of required documents for new and existing abbreviated new drug applications (ANDAs). The position also involves maintaining proper tracking, recording, storage, and archival of all incoming documents. The QA Analyst will actively participate in laboratory investigations and incidents, ensuring compliance and identifying gaps within the system during routine monitoring. Additionally, the role includes conducting random internal audits in the analytical lab and assessing compliance related to raw materials, in-process, and finished product analytical documents. The QA Analyst will also be responsible for implementing changes related to Pharmacopoeia updates and performing other departmental and cross-functional projects as assigned by the manager. This position requires a proactive approach to quality assurance, with a focus on continuous improvement and adherence to regulatory standards.

Responsibilities

  • Confirm and ensure compliance of protocols and reports of method validations, verifications, and comparison reports.
  • Monitor and ensure adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations.
  • Verify standard operating procedures (SOPs) and test procedures.
  • Verify process validation and characterization-related documents.
  • Coordinate with Regulatory Affairs and Analytical Laboratory Teams for timely submission of documents for ANDAs.
  • Maintain proper tracking, recording, storage, and archival of incoming documents.
  • Review and identify gaps within the system during routine monitoring and inform the supervisor for improvements.
  • Participate in laboratory investigations and incidents, ensuring compliance.
  • Evaluate and confirm compliance related to raw materials, in-process, and finished product analytical documents.
  • Conduct random internal audits in the analytical lab to ensure compliance.
  • Assess and implement changes related to Pharmacopoeia updates.
  • Perform departmental and cross-functional projects and assignments as directed by the manager.

Requirements

  • Bachelor's degree in chemistry, Pharmaceutical Sciences, or related field from an accredited institution; Master's degree preferred.
  • Minimum of eight (8) years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
  • Minimum of five (5) years' experience in quality assurance in a cGMP pharmaceutical manufacturing operation environment.
  • Strong knowledge and experience with analytical laboratory activities, including active pharmaceutical ingredients (API) and drug products.
  • Proficient in computer skills and software applications such as Microsoft Office and Quality applications.
  • Experience using statistical software packages is a plus.
  • Current working knowledge of quality assurance (QA) principles and practices.

Nice-to-haves

  • Experience using SAP business system and applications.
  • Experience in Inhalation products (MDI) is a plus.
  • Knowledge of good manufacturing practices and good documentation practices preferred.

Benefits

  • Relocation negotiable.
  • No remote work available.
  • Opportunity to work in a dynamic and fast-paced environment.
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