PharMEDium Services, LLC, an AmerisourceBergen Company, is a growing outsource compounding organization servicing hospitals nationwide.
The 3rd shift Quality Supervisor
will lead a staff of Quality Technicians that perform daily quality control activities. Ensures that staff performs routine tasks in a timely manner according to established Standard Operating Procedures through direct observation. RESPONSIBILITIES:
1. Will be responsible for daily quality operations within the department. Ensures compliance to procedures and addresses non-compliance issues.
2. Will provide direction, scheduling and training of the QA Technicians on new systems, procedures, and day to day activities.
3. Will conduct internal audits of processes, systems and procedures.
4. Will participate in cross-functional teams to identify effective corrective and preventive actions to improve process quality.
5. Daily activities will include but not limited to: batch processing, label and packing, environmental monitoring, training of specific procedures.
6. Will assist Quality Manager to assure timely closure of audit items.
7. Will initiate SOP revisions as needed to assure compliance, continuous improvement.
8. Will provide reports from QA and data to support other business functions as needed for continuous improvements efforts within the facility.
9. Conduct root cause analysis for compounding errors and processing errors generated at the facility during all phases of the production process.
10. Coordinate and schedule testing of all products for the on-going stability and on-going sterility monitoring programs with the appropriate contract labs (ensure product is produced and shipped to the appropriate lab in a timely manner).
11. Perform review of quality related documents.
12. Will be responsible for tracking product lots from the generation of batch records through the final disposition. This will be done through the issuance of periodic reports to management that detail the status of all lots in progress.
13. Other duties and responsibilities as assigned. Qualifications:
- Bachelor's Degree in Science or related field preferred.
- Minimum of 3-5 years' experience in Quality, Operations, or related field in the healthcare industry. (Experience in FDA/DEA regulated environment a plus.)
- Experience with LEAN Manufacturing, Six Sigma experience preferred.
- Demonstrated understanding of quality assurance in a regulated environment.
- Knowledge of Management Inventory Systems desired.
- Must be able to compile, analyze and present collected data in summary form.
- Must be able to communicate technical, scientific, and regulatory information, both written and verbally.
- Computer skills in word processing, spreadsheets and databases desirable.
- Effective problem solving, supervisory and organizational skills.
Must be a team player and enforce policies and standard operating procedures.