Document Control Coordinator I (1st shift)

americanregent; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent seeks a Document Control Coordinator to manage controlled documents and support the EDMS and change control processes. You will edit, review and file records, issue Master Batch Records and assist with regulatory inspections.

The role requires familiarity with cGMP, SOPs, EDMS and strong organizational skills, plus the ability to work independently in a team setting. Training and central archive duties are also part of the scope.

Qualifications

• High School Diploma or GED is required; Associates or Bachelor's Degree preferred.
• 0-1 year of experience in Quality Assurance or Document Control is preferred.
• Minimum 2 years of work experience in a FDA-regulated environment is preferred.
• Must be able to work independently, with minimal supervision.

Responsibilities

• Edit, review, track, issue, scan and file controlled documents in accordance with applicable SOPs and cGMP.
• Maintain revision and maintenance of controlled documents (SOPs, specifications, protocols) within the EDMS.
• Prepare controlled documents through the EDMS and change control process including 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.
• Assist internal departments by requesting controlled copies, updating on reviews, creating EDMS reports and reassigning tasks.
• Ensure all work is performed and documented per cGMP and SOPs.
• Provide training support regarding the EDMS for internal departments.
• Assist in Central Archive document intake, retrieval and maintenance.
• Perform other tasks/duties as assigned by management.

Skills

Communication skills

Teamwork

Independent work

Overtime availability

Education

High School Diploma or GED

Associate's or Bachelor's Degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

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 management's 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 Bachelor's 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: https://www.dol.gov/whd/regs/compliance/posters/fmlac/posters/fmlac

Know Your Rights: Know Your Rights: Workplace discrimination is illegal ( eeoc.gov )

Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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