DOCUMENT CONTROL

About the role

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

Responsibilities

• 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.
• Issue batch production records, track master batch records, and manage 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 backup and support to the Quality Assurance Manager.
• Initiate, carry out, and maintain change control documents.

Requirements

• Bachelor’s degree in a science field.
• 2-5 years’ experience in a 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 a strong sense of urgency while ensuring 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.

Skills

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