What are the responsibilities and job description for the IPQA Associate II position at Integrated Resources, Inc ( IRI )?
IPQA Associate will support and assist activities related to the production of pharmaceutical products in accordance with current Good Manufacturing Practices (cGMP), Standard Operating Procedures (SOPs) and batch record specification. The IPQA Associate shall assure compliance with all standards and regulatory guidelines.
- Perform cleaning verification/validation swabbing of equipment.
- Capture critical information for customer complaint/deviation investigations/ CAPA (when necessary).
- Perform complaint sample inspection.
- Conduct and verify line clearances (rooms / equipment) and components verification.
- Review and approve preventive maintenance or work orders (if necessary).\
- Monitor compliance in Manufacturing, Packaging, Product Development/Technical Services (PDTS) and Warehouse areas.
- Blend, compression, encapsulation, coating, AQL, etc. sampling.
- Perform in- process checks and finish goods inspections to ensure product conforms to batch record specifications.
- Provide quality direction to resolve floor issues, implement corrections.
- Write and revise SOPs as needed.
- Initiate change controls, write protocols, CAPAS & deviations as assigned.
- Handle various requests from departments for developmental or investigative reasons.
- Approve protocols/change controls if needed with QA Management guidance.
- Provide support to complete Annual Product Review.
- Perform annual product visual inspections.
- Participate in the execution of validation and process improvement activities.
- Train new personnel on all pertinent documents and procedures (including but not limited to their corresponding syllabus).
- Complete all applicable training forms in a timely manner and forward to document control for archival.
- Participate in site quality and process improvement.
- Perform batch record QA final review under Batch Record Coordinator’s supervision as needed.
- Follow the laid down Quality Culture Principles and Behaviors.
- Act as a site QA Personnel in E-Residue software for sampling.
- Write reports, SOPs, protocols, and other documents as applicable.
- Bachelor’s degree in related field of study preferred or have the education, training and experience to perform the assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.
- 2-5 years of pharmaceutical manufacturing experience preferred.
