Review and approve GMP documentation to support timely product manufacture and release. Responsible for activities related to providing required documentation and implementing related documentation. Administers the document control process in relation to plant wide documentation changes as needed.

• Manage and maintain the official Document Change management system for editing, revision, and control of GMP documents.  Create and maintain database to track status of documents.  Maintain original documents.
• Administer and corrdinate change control process.
• Enter departmental training records into IsoTrain and provide monthly training completion reports.  Enter information related to document changes into IsoTrain.
• Uses Veeva Vault to edit and review revised documents requiring revision or creation.  Reviews and edits documentation for accuracy and compliance to procedures. Link appropriate document changes circulating together.
• Create, manage and maintain logbook indexes and all logbooks.
• Responsible for control and maintenance of the QA Documentation file room.  Maintain and approve the official list of Approver Designees.
• Generate Veeva reports to help monitor documents in workflows as needed to follow-up on biennial review of documents and to ensure approvals are obtained in an efficient timeframe for other time sensitive project related documents. 
• Complete distribution of documents and reconcile superseded document returns after distribution.

QUALIFICATIONS

• Minimum:   BS or BA degree with previous experience in pharmaceutical manufacturing.

EXPERIENCE

• Minimum: 

• One or more years’ experience in pharmaceutical or healthcare product manufacturing or quality assurance.
• At least one year word processing cGMP documentation in a work setting.
• Background in pharmaceutical documentation and knowledge of cGMPs/FDA regulations.

• Preferred:
• Document or quality system management experience using an electronic Document/quality management system such as Veeva Vault.
• Experience in Change control writing and execution.
• Experience using databases or MS Excel for tracking and trending purposes in a work setting.

SKILLS

• Working knowledge of related business systems.
• Intermediate level desktop skills and document management (e.g. Microsoft Office) software skills.
• Must have excellent conceptual, analytical, written and verbal configuration skills.
• Ability to work under strict deadlines and changing priorities with minimal supervision.
• Strong interpersonal skills and great attention to detail are necessary.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
• Proficient in Microsoft Office applications (Word and Excel)
• Good communication skills both verbal and written
• Good time management skills and the ability ti multitask and work independently

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or program terms.

Sanofi  

STADA Group  

Novo Nordisk  

Sobi  

Merck Group  

PSI CRO  

Precision Medicine Group  

Teva Pharmaceuticals  

Costello Medical  

Clinigen