QA Analyst I

Cipla - Fall River, MA

Full-time - Mid Level

Fall River, MA

Merchant Wholesalers, Nondurable Goods

About the position

The Quality Assurance (QA) Analyst I position at Cipla, specifically within InvaGen Pharmaceuticals, Inc., is a critical role that requires a strong background in analytical chemistry and laboratory practices. This position is based in Fall River, MA, and reports directly to the Quality Assurance Manager. The primary purpose of this role is to ensure compliance with established protocols and regulations within the pharmaceutical manufacturing environment. The QA Analyst will be responsible for confirming and ensuring the compliance of protocols and reports related to method validations, verifications, and other study reports. This includes monitoring adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations, verifying standard operating procedures (SOPs), and ensuring that all documentation related to process validation and characterization is accurate and up to date. In addition to compliance monitoring, the QA Analyst will coordinate with Regulatory Affairs and Analytical Laboratory Teams to arrange necessary documentation for timely submissions related to new and existing abbreviated new drug applications (ANDAs). The role 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 addressing any identified gaps within the system. Conducting random internal audits in the analytical lab to ensure compliance and assessing and implementing changes related to Pharmacopoeia updates are also key responsibilities of this position. The ideal candidate will possess a bachelor's degree in chemistry, Pharmaceutical Sciences, or a related field, with a preference for a master's degree. A minimum of eight years of relevant work experience in a pharmaceutical manufacturing setting, particularly within the Quality function, is required. The candidate should have a strong knowledge of quality assurance practices, analytical laboratory activities, and experience in a cGMP environment. Proficiency in statistical software and Microsoft Office tools is essential, along with excellent communication and organizational skills. The QA Analyst must be able to work independently and as part of a team, demonstrating initiative and the ability to manage multiple tasks in a fast-paced environment.

Responsibilities

• Confirming and ensuring compliance of protocols and reports of method validations, verifications, and other study reports.
• Monitoring adherence to current Good Laboratory Practices (cGLP) by laboratory personnel during routine operations.
• Verifying standard operating procedures (SOPs) and test procedures.
• Verifying process validation and characterization-related documents.
• Coordinating with Regulatory Affairs and Analytical Laboratory Teams for timely submission of required documents for ANDAs.
• Maintaining proper tracking, recording, storage, and archival of incoming documents.
• Reviewing and identifying gaps within the system during routine monitoring and informing the supervisor for necessary improvements.
• Participating in laboratory investigations and incidents to ensure compliance.
• Evaluating and confirming compliance related to raw materials, in-process, and finished product analytical documents.
• Conducting random internal audits in the analytical lab to ensure compliance.
• Assessing and implementing changes related to Pharmacopoeia updates.
• Performing 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 in a related field preferred.
• Minimum of eight years of relevant work experience in a pharmaceutical manufacturing setting within the Quality function.
• Minimum of five years' experience in quality assurance in a cGMP pharmaceutical manufacturing environment.
• Strong knowledge and experience with analytical laboratory activities, including active pharmaceutical ingredients (API) and drug products.
• Proficient in computer skills and software applications, including Microsoft Office and Quality applications.
• Current working knowledge of quality assurance (QA) practices.
• Effective interpersonal relationship skills and ability to work in a team environment.
• Capable of conducting troubleshooting, investigations, and root cause analysis.

Nice-to-haves

• Experience using statistical software packages.
• Experience with SAP business systems and applications.
• Experience in Inhalation products (MDI) is a plus.

Benefits

• Relocation negotiable.
• No remote work available.
• Work in a cGMP laboratory or manufacturing environment with required personal protective equipment (PPE).
• Potential for weekend work based on business needs.