Document Control

Full Time Position – New Castle, DE

Qualified individuals will be responsible for the design, implementation, and maintenance of the Quality Assurance Documentation and Change Management. Responsibility for issuance, tracking, and control of Standard Operating Procedures, Master Batch Records, Test Records, Forms, Protocols, Amendments, and Final Reports including formatting, editing, and revisions. Serve as administrator current and future quality documentation systems and or software systems. Individual will assist the QS Manager in maintaining a complete Quality Management System (QMS) in compliance to cGMPs.

  • Create, revise and maintain company standard operating procedures (SOPs) as required.
  • Format, track and issue controlled cGMP documents including protocols, test records and forms.
  • Assist in review of cGMP controlled documents as necessary
  • Issuance of batch production records, tracking of master batch records, tracking of all batch production records and lot
  • number issuance.
  • Maintain validation files (validation protocols, validation summary reports, engineering change controls).
  • Interface with other departments regarding documentation requirements.
  • Participate in and support quality audits (internal and external), troubleshooting efforts, and other Quality System
  • processes.
  • Provide back up and support to the Quality Assurance Manager
  • Initiate, carryout and maintain change control documents


  • Bachelor’s degree in science field.
  • 2-5 years’ experience in manufacturing cGMP environment performing Quality Documentation duties.
  • Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMPs).
  • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of
  • urgency while ensuring that all cGMP and Regulatory requirements are met.
  • Excellent organizational, verbal, and technical written communication skills.
  • Solid computer skills using Word, Excel, and PowerPoint
  • Knowledge and application of good documentation practices

Additional preferences

  • The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems.
  • The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision without
  • neglecting attention to detail
  • The ability to enable and drive change while being focused on internal and external customers.
  • Capable to manage multiple priorities.
  • Proficient in Excel, Word and Microsoft Outlook.

CLICK HERE to submit resume, statement of interest and salary requirements

Marlex Pharmaceuticals, Inc. is an Equal Opportunity Employer
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties to meet the ongoing needs of the organization.