QA Analyst II

FLSA Classification

Professional, Exempt

Fall River, MA

General: 8:30AM – 5:00PM (may vary based on business needs)

AQA Supervisor

$74,984 - $102,000

This position requires a strong analytical chemistry/lab background and experience. The job duties for this position include but are not limited to the following:

The Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for Inva Gen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

• Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Prepare and review laboratory investigation (OOS/OOT/Deviation) reports and ensure compliance of same.
• Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
• Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Review of laboratory audit trials during data review against standard operating procedures (SOPs).
• Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams.
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas.
• Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.
• Performing other departmental and cross-functional projects and assignments given by the manager/supervisor.

• Possess a minimum bachelor’s degree in chemistry, Pharmaceutical Sciences, or related field of study from an accredited institution. Master’s degree in the above and/or related fields of study as noted above preferred.
• A minimum of 4-8 years in analytical (preferably in analytical quality assurance for minimum of 3 years).
• Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
• Strong knowledge and experience with analytical laboratory activities in areas such as active pharmaceutical ingredients (API), drug products, analytical development, Quality Control (QC), Good Laboratory Practices (GLP)/Good Manufacturing Practices (GMP)/Good documentation Practices (GDP), USP monograph requirements.

• Understanding of laboratory equipment operation, qualification and calibrations which includes their software audit trial reviews.
  
  E.g. HPLC, UV Vis Spectrophotometer, GC, Potentiometer, pH meter, Stability chambers, etc.
• Strong knowledge on USP monograph requirements, FDA & ICH guidance requirements, etc.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Experience in Inhalation products (MDI/DPI) is a plus.
• Ability to work in a fast-paced, dynamic environment within a manufacturing operation setting.
• Must be able to communicate clearly and concisely across all levels of the organization and possess a solid command of English language communication skills verbally, written, and interpersonally.
• Must possess strong documentation and technical writing skills, and able to apply relevant scientific principles and practices.
• Must be able to work under minimal supervision and able to work independently and in a team environment.

• Proficiently speak English as a first or second language and ability to read, write and communicate…