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Document Control Specialist in Rockville, MD at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

Job Description


We are searching for a Document Control Specialist to join a growing pharmaceutical company in Rockville, MD!  (Document Control, Pharmaceutical, Chemistry)

Responsibilities:

  • Manage the Document Control System (DCS) by initiating Document Change Orders to ensure revision of existing SOPs, to ensure creation of new SOPs, and to ensure procession the DCS to completion.
  • Interface with Contract Manufacturers in reviewing and processing documentation for approval and release of product (analytical data, specifications, labeling, batch record, etc.)
  • Manage the document routing, review and approval process.
  • Manage the implementation, distribution, maintenance, and storage of SOPs. 
  • Assist in conducting internal and external quality audits and risk assessments.
  • Manage, implement, and maintain the Training Program (new hire, GMP, continuous, and re-training).

Requirements:

  • BS in scientific discipline, chemistry preferred
  • 3+ years Relevant Document Control and/or Quality Assurance experience in the pharmaceutical industry
  • Experience working in a chemistry lab
  • Knowledge of APIs

For immediate consideration, please email your resume to Eschaffer@apexlifesciences.com with the subject 'Document Control Specialist'

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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