Job Title: QA Analyst I (AQA)
FLSA Classification: Professional, Exempt
Work Location: Fall River, MA
Work Hours: General: 8:30 AM 5:00 PM (may vary based on business needs)
Reports To: Quality Assurance Manager
Required Experience: 3 - undefined Years
Skills: laboratory quality assurance
Purpose:
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:
Scope:
The Analytical Quality Assurance (AQA) associate I position is an team contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.
The job duties for this position include but are not limited to the following:
Reviewing and confirming the compliance related to raw materials, in process 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.
Verifying the laboratory chemicals/reagents, standards for completeness of the labels against standard operating procedures (SOPs).
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.
Education and Experience:
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 1-3 years in analytical (preferably in analytical quality assurance).
Must be proficient in computer skills and software applications such as Microsoft Office tools and Quality applications and software programs.
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 Practic
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