Quality Assurance Document Control

Job Description

Job Description:

BASIC FUNCTION:
The position requires the individual to prepare customer files, review and approve batch records, and release batch records and finished product. The individual acts as the primary liaison to our customer’s quality assurance groups for batch record review and release. The position requires communication between the operations/production, project management, shipping and quality assurance groups to ascertain pertinent information relating to the contract packaging orders.

SPECIFIC DUTIES, ACTIVITIES, AND RESPONSIBILITIES:
• Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.
o Includes review of material status, protocol conformance, clinical design layout, ensuring blinding techniques are followed.
• Monitor schedule for production priorities.
• Attend scheduling meetings when needed.
• Review of completed batch record for conformance with protocol and appropriate cGMP and ensure that any changes are performed according to procedures.
• Confirm proper randomization schedule utilization for correct patient treatment group assignment.
• Primary liaison with client for batch release.
• Communicate with other functions to resolve inconsistencies with proper recording and completion of the batch record and associated documentation. Communications may include educating other functions to ensure compliance to regulations, procedures and client requirements.
• Ensure timely release of batch for protocol initiation date.
• Release batch within Scheduling database.
• Release batch within JDE inventory management system.
• Record and track errors and not-right-first-time to maintain departmental metrics.
• Archive batch documents onto shared drive and within archive room.
• Ensure that responsibilities are completed efficiently while maintaining Quality.
• Promotes a positive working environment.
• Coach new QADC staff through day to day activities when needed.
• Communicates SQDC counter measures and safety issues to Quality Management.
• Ensures QADC metrics are met or takes action to correct.
• Complies with EH&S and 5S requirements for QADC.
• Other tasks or projects as assigned.

POSITION REQUIREMENTS:
• Supervises: N/A.
• Education or Equivalent: BA/BS or High School Diploma with relevant industry experience.
• Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements):
o Attention to detail.
o Good organizational/time management skills.
o Exercises sound judgment and analytical in thought.
o Challenges status quo and initiates improvements.
o Ability to multi-task.
o Communication skills.
o Good math skills.
o Basic computer skills.

This position will be doing Batch record review and approval, support all QA Document Control Functions including filing, review, approval, GMP review of batch records. Will be in a cubical environment and very fast paced and can be loud.

• Must have 1 year experience in GMP Laws (Good Manufacturing Practices). Prefer batch record review experience.
• Must be proficient in use of computers and Microsoft Office.
• Education: High school or 2-year degree.