The Quality Assurance Investigator will review and approve Laboratory Investigations regarding exception events as well as manufacturing exceptions. This position will also provide input and assist QA management in investigating manufacturing deviations and exception documents. The Quality Assurance Investigator will also assist during regulatory/compliance/customer audit and will work alongside the Quality Assurance Manager - Investigation in ensuring compliance to company procedures and regulatory requirements through direct observations and review.
Responsible for quality review of the exception documents generated by QC investigators or Operations Investigators.
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.
Conduct internal audits of processes, systems and procedures.
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.
Assist Quality Manager to assure timely closure of audit items.
Initiate SOP revisions as needed to assure compliance, continuous improvement.
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
Must have strong attention to detail
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.
Amerisourcebergen Corporation - Corporate