Quality Assurance/Regulatory Affairs Associate

Permanent On-site
Description

Job Description
Quality Assurance / Regulatory Affairs Associate

General Duties

Conform to best practices and norms for working in a GMP environment and adhere to company health & safety policies
Standard work areas include: Production Office, Incoming materials inspection station, final inspection/packaging room, sterilizer and warehouse. Work assignments may also include any areas from the Production Operations Job Description and QMS Cleanroom.
Designate for Director of QMS
Understand and be trained to perform duties as designate of Director of QA/RA
Identify and implement training needs and ensure adequate training of designate

Non-conforming Materials
Ensure identification and isolation
Coordinate and document investigation and results
Propose, document and implement corrective or preventative actions
Coordinate and document recalls
Ensure actions taken are reviewed for adequacy

Corrective/Preventative Action
Perform and record CAPA when required
Evaluate effectiveness of CAPA and close accordingly

Monitor Cleanroom Environmental Controls
Monitor and record differential pressure of cleanroom, pack room and QMS office
Report any inconsistencies to Director of QA, Production Manager and R&D Supervisor
Conduct and document cleanroom microbial monitoring, air sampling and bioburden/endotoxin testing

Materials and Process Validation
Participate in protocol development
Participate in validation process if needed
Identify testing needs
Perform and document tests as needed

Final Inspection and Final Release of Non-sterile Products
Performs final inspection of non-sterile products coming out of the cleanroom
Perform final bulk packaging of non-sterile products for sterilization
Ensures adequacy of Device History Record

Final Inspection & Packaging of Non-sterile products for Sterilization and Release
Ensure adequate documentation of skids contents
Ensures skids transportation to/from contract sterilization facility is arranged if utilized
Send BI and proper document to test facility
Ensure that non-sterile skids of products to be sterilized are locked up in quarantine cage for pre-sterilization skids hold area
Ensure that skids received post sterilization until the batch is released after BI recovery tests results.
Inspect product skids post-sterilization for any damage during transportation if contract sterilization is utilized.
Make the skid lists and make sure product is in accordance with the list.

Quality Management System
Participate in preparation of the QMS documentation as per QMS director request
Participate in the Supplier and Vendor Review
Ensure all activities are carried out with ISO compliance in mind.
Implement customer complaint properly and track the RMA closing to the end.
Inspect the returned product for proper disposition.
Maintain QMS documentation properly.
Conduct and record new employee training.
Supervise cleaning of the facility.

Supplier Evaluation
Participate in the identification and documentation of the approved subcontractor lists.
Maintain the subcontractor evaluation file.

In-house Product Sterilization
Participate in documenting the validation and revalidation protocols, tests and validation of in house and contract facility sterilization

Receiving Inspection
Generates and maintains changes for raw materials specifications for receiving inspections.

Equipment Controls
Monitors and ensures that the companies manufacturing equipment and measuring devices are validated/calibrated per specified schedules.
Responsible for equipment set-up validation and verification in both production area and R&D lab.
Maintains Equipment History Giles for all equipment and devices and the facility.

Device History Records (DHR)
Ensures adequacy of lot related documentation.
Maintains DHR Files.
Archives DHR, quality records related to production and other quality and monitoring functions.

Batch Record Documentation
Ensures adequacy of Batch Records.
Maintains Batch Record files.
Maintains all sterilization and release documents for every load in appropriate batch record.

Regulatory References/QC Controls
Identifies, controls and files adequate referencing material for regulatory requirements.
Ensure the dissemination of regulatory information.
Identifies deficiencies in the QC process.
Ensures adequacy of communication between staff members on quality issues.

Revision of Quality System Documentation
Participate in regulatory review, adequacy and revision.
Participate in revising and maintaining the companies Quality System

Literature Review and Post Market Surveillance
Identifies need for information
Locates sources and secures copies

Quality System auditing
Participates as an internal quality auditor, in annual internal audits
Participates in preparation audits from external agencies and customer audits, as needed.
Participate in preparation of external audits.
Participate in subcontractor’s evaluation and maintain supplier’s evaluation files.

Qualifications

Education & Certification Requirements:
High school diploma or equivalent

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