QA Document Control Specialist

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

Responsibilities

• Perform 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 use in drug production and Quality Control testing.
• Monitor, manage, and develop process improvements related to data documentation, documentation management, and data integrity.
• Ensure document reviews and approvals are managed in an efficient and effective manner.
• Maintain meticulous records of document status, outstanding change controls, document reviews, and document approvals.
• Ensure documents comply with established templates, formats, and identification/naming/numbering standards.
• Maintain the electronic document library and develop or maintain a QMS document inventory that includes relevant information regarding document identification, status, effective dating, and other pertinent document control information.
• Manage and control specific quality records as required.
• Distribute and remove 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.
• Conduct QA activities as needed by the team.

Requirements

• 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.

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) and a strong background in Quality Assurance processes.
• Change agent with energy, passion, and skill to drive change.
• Strong technical aptitude (i.e., able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Demonstrated ability to effectively balance/prioritize issues.
• Strong relationship building, networking, and interpersonal skills.
• Excellent communication skills (written and oral).
• Integrity: Adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.
• External Focus: Understanding customer needs, marketplace dynamics, and the competitive landscape in the industry and considering the external impact of business activities and decisions on the external environment.
• Inclusiveness: Energizing others by building a connection with the team through personal involvement and trust, and providing feedback and coaching to help develop others.
• Clear thinker: Simplifying strategy into actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly.

Pay

For U.S. based positions, the pay range for this position is $61,600.00-$92,400.00 annually. 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.

Benefits

• Medical, dental, and vision coverage.
• Paid time off.
• 401(k) plan with employee and company contribution opportunities.
• Life, disability, and accident insurance.
• Tuition reimbursement.
• Performance-based incentive compensation, which may include cash bonus(es) and/or long-term incentives (LTI).