QUALITY ASSURANCE DOCUMENTATION SPECIALIST

Quality Assurance Documentation Specialist will be responsible for assisting in the implementation and

maintenance of the Quality Management System (QMS) by coordinating the revision, review, and

approval of SOPs and other GMP documents ensuring compliance with applicable domestic standards

and regulations. The scope of activities includes, but is not limited to, document control function,

including document login, tracking, processing, distributing, and archiving; management of CAPA, change

management, and non-conformance records; maintaining and facilitating the training program, stability

studies and QS metrics; and participating in internal audits and supporting external audits.

Duties and Responsibilities:

• Performs QA document control function, including document login, tracking, processing, approval,

distributing, and archiving in compliance to internal and external requirements (21 CFR 820, ISO

13485, 21CRF211, etc.).

• Coordinates the revision, review, and approval of SOPs and other GMP documents.

• Organizes and ensures accurate and reliable filing systems for the paper-based GMP documents.

• Selects, evaluates, and implements electronic document processing and archiving systems.

• Maintains and facilitates training programs including training matrix, training files, and annual audit of

training files.

• Processes and provides timely and accurate update of stability studies.

• Reviews quality outputs, change control, validation and qualification documents.

• Maintains change control and deviation processes for SOPs, master batch records, specifications,

test methods, validation protocols/reports, technical protocols/reports, and other GMP documents.

• Assists in Quality Investigations.

• Generates Incident Reports, Change Controls and CAPA reports, including reviewing adequacy of

root cause, corrections, corrective actions, preventative actions and effectiveness.

• Updates and maintains Quality Assurance Operations logs and databases and generating metrics as

needed.

• Participates in internal audits and supporting external audits.

Knowledge and Skill Requirements:

• BS Degree in scientific discipline.

• Quality professional with 2-5 years of hands-on experience with document control process in bio-

pharmaceutical industry.

• Experience with electronic document management system is a plus.

• Well-organized and detailed oriented professional, with strong verbal and written

communication skills.

• Good computer skills with working knowledge of MS office, such as Word and Excel, Access and

Adobe Acrobat professional.

• Must be self-motivated with ability to handle, organize and prioritize multiple tasks and be able to

perform under pressure to meet deadlines.

• Proven ability to identify quality issues/discrepancies and effectively and proactively resolve the

issues/discrepancies in a diplomatic, flexible and constructive manner.

14-102