Become A Quality Assurance Specialist

* Develop and implement Quality Assurance processes and systems.
* Act as custodian for various Quality Assurance processes (Change Control, Calibration, etc.) as assigned.
* Write, edit, and review Standard Operating Procedures and various Quality related technical documents (protocols, specification, work instructions, batch records, etc.) in a highly collaborative environment.
* Conduct Quality Event investigations (Nonconformance / failure, deviation, CAPA, etc.) and document in appropriate reporting methods and systems.
* Participate in internal Quality System / cGMP audits.
* Review batch documentation for correctness and completeness, and to release product for further processing or commercial trade.
* Review, prepare and perform qualification and periodic review activities for laboratory instruments/equipment
* Review the design and implementation of instruments/equipment to assure that security and data integrity are maintained
* Other duties as assigned

* Support Quality Assurance Manager with reviewing complaints for potential safety/non-safety issues and determination of regulatory Medical Device Reporting (MDR).
* Prepare and file Medical Device Reports (MDRs) with FDA and/or equivalent European regulatory agency.
* Analyze and prepare periodic trend analysis which are presented during management reviews and Global Sourcing Corporate Brand Trend Analysis to track and take appropriate corrective and preventative action to ensure patient safety and compliance with regulatory reporting requirements.
* Assist during FDA, ISO 13485 or other third party inspections involving complaint handling assessments or post market vigilance activities and product recall effectiveness checks.
* Conduct and coordinate appropriate adverse awareness training to Customer Service, Sales Teams, Field Satisfaction Teams and Distribution Centers.
* Develop, implement and update policies and procedures to ensure ongoing compliance with complaint handling and product recall requirements.
* Additional responsibilities may include:
* Assist with preparing, documenting and conducting Quality Assurance Audits of Distribution Centers, joint Ventures, X
* Ray Centers, private label manufacturers, non-manufacturing suppliers of Medical Devices and Pharmaceuticals.
* Conduct Quality Assurance Audits as scheduled and ensure the effective and timely facilitation of suppliers and internal quality audits and follows-up on CAPAs/Observations.
* Stay current with new or potential business opportunities, and prepare for all QA activities.
* Research applicable FDA, ISO and ASTM standards to ensure the company’s ongoing compliance with U
* S. and International Regulatory Requirements (Medical Devices Directives and FDA QS requirements).
* Conduct annual analysis of type of audits conducted and type of observations.
* Approve packaging/labels for all private label products to assure compliance with regulatory requirements
* Provide support to Corporate Brand Development Group, answering questions pertaining to regulatory issues with outsourced products and communicate to regulatory bodies as required.
* Participate in special projects and perform other duties as required.
* Intermediate level professional role.
* Some evaluation, originality or ingenuity required to perform tasks.
* Know and apply the fundamental concepts, practices, and procedures of a particular field.
* Apply company policies and procedures to resolve a variety of issues.
* Work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
* Exercise judgment within defined procedures and practice to determine appropriate action.
* Build productive internal/external working relationships.
* Normally receive little instruction on day to day work, detailed instruction on new projects or assignments.
* Typically 2 to 4 years of related professional experience.
* Bachelor's Degree or global equivalent in Pharmaceutical Sciences, Chemistry or related discipline.
* Professional skills with an understanding of industry practices and company policies and procedures.
* Developing proficiency with tools, systems, and procedures.
* Good planning/ organizational skills and techniques.
* Developing problem solving skills.
* Good writing and communication skills.
* Typically hold 1 or more industry certifications (ASQ, RAPS, ISO or equivalent).
* Excellent conflict resolution skills.
* Good decision making skills.
* Excellent interpersonal skills.
* Exercise judgment within defined procedures and practices to determine appropriate action.
* Direction from manager/director is needed on some issues.
* General knowledge of ISO 9001 and 13485 certification and maintenance.
* Less than 30% travel to and from suppliers and/or HSI facilities
* Office environment

* Ensures that quality software is provided for release to production by independently executing test scripts.
* Create, modify, and run test plans/cases to certify system functionality and/or changes.
* Review requirements, specifications and documentation to gain a thorough understanding of the programs and processes to be certified.
* Distribute test results to development staff to satisfy adequate unit testing.
* Maintain test databases and ensure their integrity and currency.
* Provide or validate estimates for assigned tasks

* Other duties may be assigned)
* Provide support for any quality initiatives (related to revenue related work product) within the Shared Services Center (SSC).
* Review work product from various SSC departments for accuracy and appropriate processing (best practices).
* Identifies performance improvement opportunities based on needs identified through data audits.
* Gathers business requirements for training development via identification of trends during the quality verification process.
* Provides data interpretation and act as a SME (subject matter expert) for the training team as needed.
* Provide class room support to the training team as needed.
* Assist with maintenance of QA work instructions and processes related to training for the various revenue cycle positions within SSC

* Provide Quality oversight to manufacturing operations
* Support Incoming material inspection and release
* Supplier Quality Oversight
* Support robust investigation into manufacturing deviations and facilitates timely identification of root cause and closure of the deviation.
* Perform lot release activities such as batch record review.
* Independently writes and/or reviews SOPs, technical reports, project plans, etc.
* Demonstrates complete knowledge of quality and manufacturing operations including both technical and compliance aspects.
* Demonstrates understanding of current aseptic manufacturing best practices.
* Supports implementation of quality assurance continuous improvement initiatives.
* May also present/defend QA Quality Systems during audits/inspections.
* This role may also require weekend work and some movement between shifts to support manufacturing operations as required