Role Summary:

The successful candidate needs strong computer background, attention to detail and good communication skills. This position works with colleagues of all levels at the site and with off-site customers as well. The Sr. Document Control Supervisor is responsible for owning and maintaining the sites Doc Control Program to include management of documentation and assessing and ensuring document control processes are performed in compliance with FDA, SOPs, and cGMP guidelines. This includes procedural changes and training colleagues on document control policies, procedures, and system. Also, act as system admin for all GMP controlled documents such as SOPs, Forms, Batch Records, printed material, specifications, device design documents (DHF documents) etc.

Role Responsibilities:

• Supervise staff in the Document Control Department
• Act as System Admin for Document Control System and electronic logbook system
• Develops policies and procedures regarding document control
• Facilitate improvement as it relates to document management across multiple departments
• Maintain and revise Document Control Standard Operating Procedures for process improvements
• Performs manufacturing investigations and CAPAs relating to document control and implement associated actions
• Responsible for completing internal assessments and audits regarding document control
• Train new colleagues on document control policies and procedures.
• Ensure personnel are properly trained and provided the tools necessary to succeed
• Oversees creations of and changes to all GMP documentation under document control
• Compile, assemble, trend and review data for the Annual Product Review (APR) as
• needed.
• Formats SOPs within the DMS
• Coordinates and maintains SOPs within the DMS. Updates files as changes, deletions, and new SOPs are issued.
• Maintains and publishes master listing of the following: Analytical Procedures, Standard Methods of Analysis, Material Specifications, and Controlled Forms; OR maintains all aspects of SOP numbering, routing, and reporting through DMS.
• Maintains accurate and complete documents.
• Performs other duties relating to QA Documentation or special projects as assigned by management for increased productivity within department.
• Creates and maintains database tracking systems throughout the QA Documentation department.
• Support other functions, other duties within the quality department as required.
• Assist, as necessary, with external audits by regulatory bodies or contract customers.
• Oversees the Logbook program and ensures all logbooks are created, issued, and reconciled per procedure. Admin for logbook system.

Role Requirements:

• Bachelor's degree in science, engineering, computer science, or related technical discipline.
• Minimum five (5) years of experience in a pharmaceutical, medical device environment.
• Excellent self-management, time management, and problem solving skills; must be able to multi-task / multi-project.
• Proficiency in Microsoft Office Suite (Excel, Word, Outlook, etc.) is required.
• Demonstrated proficiency using office software applications and imaging technology and related storage requirements, image and document formats, metadata, or image enabled databases
• Fluent in English both speaking & writing.
• Experience with preparation and/or facilitation of regulatory inspections (FDA, EMA, etc.) preferred.
• Computer Skills - To perform this job successfully, an individual must have knowledge of Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook, Microsoft Visio, Adobe Professional.

Physical Requirements:

• While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts. The noise level in the work environment is usually moderate. While performing the duties of this job, the employee is occasionally required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms and talk or hear; ability to lift up to 25 lbs; sometimes exposed to loud noise.
• Work independently, with minimal supervision, under strict time guidelines; Stress (system owners/users expect immediate attention to and resolution of problems); Flexibility/organizational skills; speed and dexterity required.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.

Travel or Schedule Requirements:

• Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. Note that these activities may not be time bound to core hours or presence at the site.
• Controlled Laboratory, Production and Warehouse environments requiring safety glasses, lab coats, steel-toed shoes and gloves (as applicable) be worn at all times.
• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
• Travel between Brentwood and Westport locations required.
  Meridian Medical Technologies (MMT) is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. MMT also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

  MMT requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, MMT will consider requests for Reasonable Accommodations.