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Quality Assurance Associate II
2 months ago
The Quality Assurance Associate II will be responsible for overseeing manufacturing and production activities to ensure products meet quality and safety standards.
Key Responsibilities:- 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.
- Ability and willingness to learn manufacturing/packaging procedures and federal regulations pertaining to manufacturing process.
- Experience with proper documentation and cGMP.
- Must read, write and speak English.
- Must be a Team player able to effectively communicate with QA Supervisor, IPQA, Quality Control, Production, and Supply Chain to meet finished product release goals.
- Must be able to work overtime hours to support production requirements, including weekends, as needed for production support, with minimal notice.
- Basic skills with Microsoft Office Suite (Outlook, Word, Excel, etc.).
- 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.
