QA Document Control Specialist

Job Description SummaryThis position involves working within the QA Department to perform Document Control functions and to support compliance functions. You will provide administrative support to the quality function and create the compilation of the various reports required both internally within the department and externally. You will support other Quality Assurance activities as needed.

Job Description

Responsibilities:

• QA performance of document control activities including the management of document lifecycles, monitoring periodic review, and supporting the site’s document management of change lifecycles.

• Determine and implement problem solving and corrective action related to department and documentation processing activities.

• Act as an administrator for the Electronic Document Management System and Training Management System

• Issue controlled documents for the use in drug production and Quality Control testing

• Monitor, Manage, and Develop Process Improvements related to data documentation, documentation management, and data integrity

• Ensuring that document reviews and approvals are managed in an efficient and effective manner. 

• Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained. 

• Ensuring that documents comply with established templates, formats, and identification/naming/numbering standards. 

• Maintaining the electronic document library and developing and/or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating and other pertinent document control information, as required. 

• Managing and controlling specific quality records, as required. 

• Distributing and removing controlled documentation to/from points of use, as required. 

• Monitor the document archival and retention lifecycles including corresponding with internal customers and outside vendors

• Support the Compilation of QA Monthly Reports and provide administrative support

• Conducting QA activities as needed by the team.

Required Qualifications:

• Bachelor's degree (OR will consider a high school education and a minimum of 5 years experience in a GMP controlled environment)

• Experience using document control strategies or methods in a GMP controlled environment.

• Knowledge of MS Office products as well as the ability to learn new systems as required.

• Ability to communicate using English.

• Prior experience using word processing, spreadsheet, and presentation software.

Preferred Qualifications:

• Demonstrated experience in a regulated business, preferably healthcare industry.

• Knowledge and experience with Quality Systems policies and regulations (ISO, FDA, and other key regulatory bodies) & strong background in Quality Assurance processes

• Change agent with energy, passion & skill to drive change

• Strong technical aptitude (i.e. able to read & comprehend technical documentation, ability to comprehend & execute procedures, demonstrated understanding of system documentation)

• Demonstrated ability to effectively balance/prioritize issues

• Strong relationship building/networking/interpersonal skills

• Excellent communication skills (written & oral)

• Integrity: Adhering to high ethical, moral & personal values in decisions, communications, actions & when dealing with others

• External Focus: Understanding customer needs, marketplace dynamics & the competitive landscape in the industry & considering the external impact of business activities & decisions on the external environment

• Inclusiveness: Energizing others by building a connection with the team through personal involvement & trust & providing feedback & coaching to help develop others

• Clear thinker: Simplifying strategy into actions with clear accountability, making decisions with speed & accuracy based on best available information & communicating priorities clearly

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $61,600.00-$92,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.