Job Opening - Sr.Quality Assurance Documentation Specialist
B asic Function and Responsibility:
The Quality Assurance Documentation Specialist Is responsible for developing,
implementing, maintaining and refining documentation management, change control, SOPs Methods and Specifications, APR
(Annual Product Review) and Training systems. The systems accommodate official corporate documents throughout their lifecycle,
from creation to destruction. The systems are comprised of both paper-based and electronic databases for purposes of Information tracking,
storage, and retrieval. Also responsible for word processing and administration of documents utilizing PC software, controlling approved hardcopy
and associated electronic documents. Assigns document control numbers and reviews documents for content, applicability and compliance,
assigns effective dates, issues and retrieves approved documents. Responsible for maintaining SOP related training records for all employees.
Responsible for compiling Annual Product Reviews. As a team leader or member, the Documentation Specialist may also be responsible for
accomplishing quality related projects that may be outside the realm of document control.
W ork Performed:
The Documentation Specialist is responsible for maintaining originals and preparing copies of documents
for distribution, not limited to the following examples:
Standard Operating Procedures (SOPs)
Process, Cleaning and Equipment Validation Reports.
Raw Material, Stability, Packaging Component and
Finished Product Specifications & Reports.
QC and ARMD Chemical Testing Monographs.
Annual Product Reviews (APR)
Change Control Request (CCRs)
Maintaining Training database and Training Compliance.
The Documentation Specialist will assist the Quality and Regulatory Department with various projects, as required.
A spects of Performance:
Possesses sound analytical problem-solving
and documentation skills.
Demonstrates ability to prioritize
Executes assigned tasks within established
Writes and speaks clearly and concisely.
Develop and maintain expertise through
continuing professional education and training.
Comply with company policies, procedures,
rules and regulations.
Possesses excellent judgement, decision,
organizational, communication and Interpersonal skills.
Requirements include a working knowledge of documentation,
Training compliance and change control management practices. Excellent knowledge of cGMP
regulatory requirements, quality system standards and current industry practices. Must be proficient
with Microsoft Office Suite software and have strong computer and organizational skills.
B.S./B.A. in a Life Science, Chemistry or equivalent.
Minimum of 5 to 7 years experience in a scientific discipliner
technical documentation and/or a quality assurance environment.