Employment Opportunities:

Document Control Specialist – Bannockburn, Illinois

The Document Control Specialist will report to the Director, Quality Assurance and will process, distribute, and maintain controlled documentation using Cytochroma documentation Management System.  This position will process documents for revision and approval, monitor the distribution and reconciliation of process or reference documents, and will train staff on document control and procedures.

Key Responsibilities:

• As SOP Administrator, provide maintenance and version control of Standard Operating Procedures in electronic as well as paper documentation that captures Cytochroma GCP, GMP, GLP procedures and practices.
• Cultivate electronic folder structure of SOPs with regard to draft versions, original signature pages, and PDF Final versions.
• Plan and implement an electronic file storage hierarchy for intra-company storage and access to CMC documentation filed by compound/project number, i.e., Audit reports, quality agreements, contracts, vendor/ supplier qualification forms, batch reports, stability outlines.
• Conduct review & approval cycles for new Standard Operating Procedures; electronically publish approved SOPs, SPs and Forms for broadcasts to company intranet.
• Gatekeeper for accuracy of updates to management copies of SOP Binders.
• Collect CMC hard copy wet signature documents; scan and upload to Quality Assurance Access tracking tool.
• Uphold working relationships with Markham office document filing personnel. Send select wet signature documents to Markham personnel, share knowledge of these approved and final documents in shared Excel matrix spreadsheets.

Skills & Qualifications:

• Advanced experience and knowledge of MSOffice software: PowerPoint, MSWord, and Excel.
• Working knowledge of Access.
• Knowledge of medical terminology terms, and chemistry measurements.
• Experience with FDA Guidances as available for usage in regulatory issues related to documentation control, storage of documents, filing schemes for paper as well as electronic documentation; FDA submissions criterion.
• Having proper knowledge in management and administrative functions are essential. Additionally, the document control specialist must possess the ability to coordinate and plan strategically, proficient in communication and be able to maintain critical thinking.

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in the subject line of your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.