Documentation Control Lead - Pharmatek Consulting Inc

The Document Control/QA Specialist will be responsible for maintaining the lifecycle of validation documents within an automated system. This role involves performing quality reviews of validation protocols, ensuring compliance with internal and regulatory standards.

Key Responsibilities:

• Manage validation documentation in automated systems, including document control and archiving.

• Perform quality reviews of IQ/OQ/PQ protocols, test scripts, and validation reports.

• Collaborate with the CQV and engineering teams to ensure documentation aligns with project milestones.

• Assist in audits and inspections by providing necessary documentation.

• Ensure all document control activities comply with FDA, cGMP, and internal quality standards.

Requirements

Qualifications:

• Bachelor’s degree in Life Sciences, Engineering, or related field.

• 8+ years of experience in document control and quality assurance in pharmaceutical settings.

• Expertise in validation documentation management and quality review processes.

• Strong understanding of regulatory requirements, including FDA and cGMP.

• Excellent attention to detail and organizational skills.

At least 3 years’ experience/ knowledge with automated systems, including programming and improving complex systems Familiarity with at least one computer coding language (such as Python, Java, C#, HTML), understanding in version control systems (like GitHub or GitLab) is a plus Able to independently contribute through development and optimization of automation technologies preferred. Able to oversee implementation of automation technologies with third parties through technical skills and project management principles Must be able to work productively in an interdisciplinary team environment Experience with Hamilton, Scinomix, Tecan or similar automated laboratory platforms preferred Good oral and written communication, problem-solving, and analytical skills Ability to influence and educate other scientists and engineers to use automation technologies as part of implementation Proficiency using PC and Microsoft Office tools Excellent organizational and time management skills Strong attention to detail GMP and Good Documentation Practice Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes) Basic skills with EXCEL and PowerPoint Experience with and tolerance for high levels of challenge and change Experience with project management including capturing project requirements and deliverables, timeline development, stakeholder management and communications