Sr. QC Technical Documentation Specialist

Role Summary

Sr. QC Technical Documentation Specialist. Responsible for preparing, reviewing, and maintaining essential GMP/GLP/GCP documentation, and for managing documentation systems within a pharmaceutical quality environment. Plays a key role in ensuring regulatory compliance and high-quality documentation across manufacturing and R&D activities.

Responsibilities

• Prepare, review, and maintain essential documentation, including GMP, GLP, and GCP manuals.
• Create and edit procedure manuals, quality control manuals, engineering documents, manufacturing instructions, and change authorizations in compliance with company policies and government regulations.
• Implement and manage documentation systems, propose change control processes, and coordinate the review and approval of procedures and forms.
• Provide input on quality control procedures and R&D documentation, and act as an advisor due to extensive knowledge and skills.
• Identify innovative solutions to problems, foster collaboration and communication within the team and across groups.
• Train and guide team members, manage time and professional development, and allocate tasks to others.
• Route documents through the Document Management System (DMS) for reviews and approvals.
• Process documentation for effective dating, and handle creation, distribution, retrieval, and storage of production logbooks.
• Maintain the filing system in the Documentation department, review and approve documents in the change control system, and initiate/change requests in the Quality Management System (QMS).
• Adhere to plant safety rules, SOPs, and TCPs, and stay current with training requirements.

Qualifications

• Minimum of 5 years‚Äô experience in a science/technical related position; pharmaceutical industry preferred.
• 3 years‚Äô experience in a manufacturing site.
• 3+ years in a pharmaceutical facility.
• Excellent verbal and written communication skills and attention to detail.
• Proficient with Microsoft Office.
• Experience in SAP, QTS, DMS, PDOC system and Change Control preferred.
• Experience with Compendial Monographs and General Chapters.
• Ability to organize data from multiple sources, extract key information, and write reports and summaries.
• Demonstrated ability to write logically and consistently.
• Strong critical thinking and problem solving skills.
• Resourceful and innovative approach, and ability to work cross-functionally with a diverse team.

Skills

• Strong documentation management and process improvement skills.
• Quality systems, change control, and document control proficiency.
• Analytical thinking and attention to detail.
• Cross-functional collaboration and communication.

Education

• Not specified

Additional Requirements

• Physical/mental: Stand up to 8 hours, sit up to 8 hours, walking, stairs, and use of protective clothing; repetitive upper-extremity work.
• Non-standard schedule: Some nonstandard scheduling as needed to support business objectives.