Job Opening - Sr.Quality Assurance Documentation Specialist
G & W Labs - South Plainfield, NJ

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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) and Forms.

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:

Maintains confidentiality.
Possesses sound analytical problem-solving and documentation skills.
Demonstrates ability to prioritize conflicting demands.
Executes assigned tasks within established schedule.
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.

Q ualifications:

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.

E ducation:

B.S./B.A. in a Life Science, Chemistry or equivalent.

E xperience:

Minimum of 5 to 7 years experience in a scientific discipliner technical documentation and/or a quality assurance environment.

G & W Labs - 15 months ago - save job - block