Document Control Coordinator I (1st shift)

Nature and Scope

This position is a member of the Document Control Group. The Document Control Group is responsible for controlled documents associated with the manufacture of safe pure effective and sterile pharmaceuticals in accordance with company SOPs policies and cGMPs. The Document Control group provides support to other departments as needed and is critical in maintaining production schedules and meeting company goals. The Document Control Coordinator will participate in all aspects of the Document Control Process. This includes all elements of the document lifecycle such as editing reviewing tracking issuing scanning and filing of controlled documentation as per applicable Standard Operating Procedures. The Document Control Coordinator works under the direct supervision of senior management in Quality Assurance and senior members of the Document Control sGroup.

Essential Duties and Responsibilities

Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time.

• Responsible for the revision and maintenance of controlled documents including Standard Operating Procedures specifications protocols and other miscellaneous documents within the Electronic Document Management System (EDMS).
• Prepare controlled documents through the EDMS and change control process. This includes editing proofreading tracking printing scanning and filing.
• Issue Master Batch Records to production in accordance with SOPs.
• Provide support for regulatory inspections and partner audits.
• Responsible for providing support to internal departments by requesting controlled copies updating departments on periodic review creating/sharing EDMS reports and reassigning tasks as needed.
• Ensure all work is performed and documented in accordance with cGMP requirements and standard operating procedures.
• Able to perform tasks with minimal error rate.
• Provides training support regarding the EDMS for internal departments.
• Assist in Central Archive document intake retrieval and maintenance.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

To perform this job successfully an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill and/or ability required.

• High School Diploma or GED equivalent required. Associates or Bachelors Degree preferred.
• 0-1 year experience in Quality Assurance or Document Control function is preferred.
• Minimum 2 years work experience in a FDA regulated environment is preferred.
• Must be able to do work independently recognizing what needs to be done and accomplishing it with minimal supervision.
• Intermediate skills in Microsoft Word and Excel are required.
• Excellent organizational interpersonal and communication skills (written and oral) required.
• Ability to take feedback constructively and function in a team oriented work environment.
• Ability to work overtime as needed.

Physical Environment and Requirements

• Employee must be able to occasionally lift and/or move up to 25 pounds.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin disability status or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: Your Rights: Know Your Rights: Workplace discrimination is illegal ()

• Employee Polygraph Protection Act: Were aware of individuals impersonating our staff to target job seekers. Please note:

  All legitimate communication will come directly from a verified ARI recruiter either by phone or via an email address.

  Our recruiting process includes multiple in person and/or video interviews and assessments.

  If you are unsure about the legitimacy of a message contact John Rossini at before responding.

  We never request payment bank information or personal financial details during our offer process.

  Your security is important to us and we encourage you to stay vigilant when job searching.

  American Regent Inc. endeavors to make accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process please email .