QA Investigator

AmerisourceBergen Corporation - Corporate • Sugar Land, TX 77487

Posted 2 weeks ago

Job Description

The Quality Assurance Investigator will review and approve Laboratory Investigation regarding exception events as well as manufacturing exceptions. S/he will also provide input and assist QA management in investigating manufacturing deviations and exception documents. S/he will also assist during regulatory/compliance/customer audits. S/he will work alongside the Quality Assurance Manager - Investigation in ensuring compliance to company procedures and regulatory requirements through direct observations and review.

PRIMARY DUTIES AND RESPONSIBILITIES:

* Will be responsible for quality review of the exception documents generated by QC investigators or Operations Investigators.

* Will provide direction, scheduling and training of the QA/QC/Operations personnel on new systems, procedures, and day to day activities as relates to conducting investigations of the deviations and exception events.

* Will conduct internal audits of processes, systems and procedures.

* Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.

* Daily activities will include but not limited to: review and approvals of the exceptions related to the QC laboratory procedures, batch processing, label and packing, environmental monitoring, training of specific procedures.

* Will assist Quality Manager to assure timely closure of audit items.

* Will initiate SOP revisions as needed to assure compliance, continuous improvement.

* Will provide reports from QA and data to support other business functions as needed for continuous improvements efforts within the facility.

* Assist to conduct root cause analysis for compounding errors and processing errors generated at the facility during all phases of the production process.

* Perform review of quality related documents as needed.

* Other duties and responsibilities as assigned.

* Bachelor's Degree in Science or related field preferred.

* Minimum of 2-3 years' experience in Quality, Operations, or related field in the healthcare industry. (Experience in FDA/DEA regulated environment a plus.)

* Aseptic processing experience is a plus

MINIMUM SKILLS, KNOWLEDGE AND ABILITY REQUIREMENTS:

* Attention to details.

* Computer skills in word processing, spreadsheets and databases required.

* Effective problem solving, supervisory, strong communication (written and verbal) and organizational skills

* Must be able to communicate technical, scientific, and regulatory information, both written and verbally.

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