CAPA & Change Control Specialist

Job Title:

CAPA and Change Control Specialist

Responsibility:

·   Administer the CAPA process and Change Control process for GBO NA, Inc. 

·   Provide support for CAPA for manufacturing process.

·   Organize and administer CAPA meetings. Drive CAPA progress together with Vice President of Operations and QRM.

·   Evaluate CAPA acceptance, root cause investigation and action items together with process owners and QRM.

·   Provide support for process owners to ensure  corrections are timely and supply chain functions are aligned with investigation progress and results.

·   Participate in internal and intersite continuous improvement efforts by GBO project teams for CAPA and Change Control.

·   Ensure all deviations from established procedures are appropriately documented and investigated for root cause. Requires direct input on the creation and effectiveness of corrective and preventive action plans.

·   Assist with implementation and supporting on-going continuous improvements.

·   Identify, develop and implement process robustness improvements through lean principals.

·   Support site change controls as needed.

·   Responsible for maintaining quality standards to meet FDA  requirements, CFRs, and internal company policies with respect to the CAPA and Change Control processes.

·   Responsible for investigating complex deviations and supporting the applicable CAPAs discovered in the upstream, downstream, manufacturing.

·   Ensure our programs and manufacturing are in a state of control and processes feeding into the CAPA System are monitored.

·   Maintain current procedures and execute quality functions within the Change Control/CAPA processes.

·   Review change control information for accuracy and conformance to established guidelines and procedures.

·   Other duties as assigned.

Authority:

 

·   Issues CAPAs.

·   Represent QM for CAPA root cause investigation and effectiveness check.

·   Write and read and delete access for electronic Quality folders and files.

·   Write and read access for CAPA system, eQMS, and GBO internal system.

·   Communicate with other departments and intersite on matters of Change Control and CAPA.

·   Calls and organizes CAPA and Change Control meetings to drive the processes.   

Job Requirements:

 

·   College degree in life engineering or in science field, preferable Medical Technology

·   Experience with either ISO 13485, or FDA GMP.

·   Experience in Quality Assurance functions and Quality Compliance functions strongly preferred.

·   Must have past experience in Quality and manufacturing process.

·   Must have very good communication and medical writing skills.

·   Proficient computer skills in Microsoft Excel and Word.

·   Must pass pre-employment examination, qualification test.

Physical Requirements:

·   Must be able to sit, stand and walk for 8 ½  hours.

·   Must be able to lift 50 lbs.

·   Must have an appropriate vision to perform detailed inspections as outlined in SOPs or TPs.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, creed, color, sex, sexual orientation, gender identity, genetic information, age national origin, veteran status, physical or mental disability or any other characteristics protected under applicable federal, state or local law.

 

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