Specialist II, QA Document Control

ADMA Biologics Inc•South Burlington, VT

42d

About The Position

The Specialist II, QA Document Contro performs a wide variety of Quality Assurance activities to ensure compliance with regulatory requirements. Writes, revises, processes cGMP documents such as: Standard Operations Procedures (SOPs), Forms, and Batch Records. May conduct investigations related to manufactured products.

Requirements

Ability to follow the cGMP's and procedures with great attention to detail
FDA Adherence
High school diploma required.
3-5 years' experience in pharmaceutical or biotechnology industry or other related industry.

Responsibilities

Coordinates projects as assigned by management such as developing new procedures.
Ensures regulatory compliance as defined in government regulations CFR 210, 211, and 600.
Writes, reviews, and processes SOPs, investigational reports, and other controlled documents.
Discusses and researches fundamental technical and regulatory issues.
Understands, originates, and processes QA Quality System documents such as deviations, CAPAs, change controls, and OOSs.
Reviews all QA system documents and makes suggestions for continuous improvement and efficiency.
Trains others in the approval process for QA system documents such as deviations, change controls, CAPAs and protocols.
Proficient in cGMPs.
Develop and execute monthly reporting of Quality Systems Key Performance Indicators (KPI), track and trending (QSRB), and training tasks.
Provide leadership on work scheduling and prioritization.
Proficiency in computer systems requirements, validations, role, and training assignments.
Willingness to take on new projects.