QA Document Control Specialist

Job Description:

Job Title: Quality Assurance document Control

Work Location: 10381 Decatur Rd, Philadelphia PA 19114 United

Duration of project: 12 months contract (With possible extension)

Training: 3 months - 10am to 6:30 pm (Mon – Fri)

Purpose:

· 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.

Responsibilities:

· Review and approve all batch records prior to production to ensure that they conform to requirements of cGMP and Clinical Trial Protocol.

· 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

· 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.

Job Type: Contract

Salary: $25.00 - $27.00 per hour

Benefits:

• Referral program

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Education:

• High school or equivalent (Required)

Experience:

• CGMP: 1 year (Preferred)
• Batch Records: 2 years (Preferred)
• Warehouse and production: 2 years (Preferred)
• Clinical documentation improvement: 2 years (Preferred)

Work Location: One location

Speak with the employer
91 862-300-5030

Salary : $25 - $27