Specialist II, QA Document Control

Role Summary

Specialist II, QA Document Control in Boca Raton, FL. Performs a wide variety of quality assurance activities to ensure regulatory compliance and manages cGMP documents such as SOPs, forms, and batch records.

Responsibilities

• Coordinates projects as assigned by management, such as developing new procedures.
• Ensures regulatory compliance as defined in 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 suggests 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.
• Develops and executes monthly reporting of Quality Systems KPI, tracks and trends (QSRB), and training tasks.
• Provides leadership on work scheduling and prioritization.
• Maintains proficiency in computer systems requirements, validations, role, and training assignments.
• Willingness to take on new projects.

Qualifications

• Required: High school diploma.
• Experience: 3-5 years‚Äô experience in pharmaceutical or biotechnology industry or related field.
• Preferred: Compliance with ADMA Quality policies, standards, and SOPs; ability to ensure timely completion of QA records, HR policies, and EH&S practices.

Skills

• Attention to detail and ability to follow cGMPs.
• Strong regulatory knowledge and document control skills.
• Proficiency with QA systems, deviations, CAPAs, change controls, OOSs, and related records.

Education

• High school diploma required.

Additional Requirements

• None beyond the listed qualifications and responsibilities.