Sr. QC Technical Documentation Specialist

Role Summary

Sr. QC Technical Documentation Specialist

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 policies and regulations.
• Implement and manage documentation systems, propose change control processes, and coordinate review and approval of procedures and forms.
• Provide input on quality control procedures and R&D documentation, and act as an advisor to colleagues 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 while allocating tasks to others.
• Act as the go-to person for key administrative expertise, route documents through the Document Management System (DMS) for reviews and approvals.
• Process documentation for effective dating as directed, handle creation, distribution, retrieval, and storage of production logbooks.
• Maintain the filing system within the Documentation department, review and approve documents in the change control system, and initiate and facilitate change requests in the Quality Management System (QMS).
• Adhere to plant safety rules, SOPs and TCPs, and stay current with all training requirements.

Qualifications

• Minimum of 5 years’ experience in a science/technical related position; pharmaceutical industry preferred.
• 3 years’ experience in a manufacturing site.
• 3 or more 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.
• Capable of organizing data from multiple sources, extracting key information and writing reports and summaries.
• Demonstrated ability to write logically and consistently.
• Strong critical thinking and problem solving skills.
• Resourceful and innovative approach.
• Ability to work cross-functionally with a diverse team.

Skills

• Documentation management
• Quality systems (DMS, QMS)
• Change control
• Technical writing
• Cross-functional collaboration

Education

Additional Requirements

• Physical/mental requirements: Stand up for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, wearing protective clothing, repetitive use of upper extremities.
• Non-standard work schedule, travel or environment: No out-of-the-ordinary travel or shift requirements; may work nonstandard schedule as needed.