The Quality Assurance Packaging Manager is directly responsible for packaging Quality Operations at the Hayward, CA site. Responsibilities include the direct supervision of QA Inspectors, controlled label room, batch record review/disposition, incoming sampling/disposition of materials and components. Plans, coordinates and directs the quality assurance program designed to ensure that the packaging of products is consistent with established standards and quality systems.
Additional responsibilities include conducting process/product audits, reviewing procedures to assure conformity to cGMPs/Impax procedures, and conducting investigations related to raw material/ packaging components/process nonconformance’s and/or deviations.
Essential Duties & Responsibilities:
- Supervision of the QA Inspectors to assure the department responsibilities are being executed as per written instructions and in accordance with cGMP requirements. Oversee the sampling and inspection function for raw materials, packaging components and labeling.
- Act as a QA liaison between Quality and Supply Chain to ensure timely release of materials and scheduling of packaging.
- Oversee the Product/ Material systems. Perform SAP Transactions related to the disposition of raw materials and packaging components. Perform the final disposition for all incoming materials (components, raw materials and bulk).
- Establish key quality metrics for the department and monitor performance in meeting objectives, efficiency standards and conformance to cGMP compliance regulations; recalibrate metrics as required.
- Lead and participate in FDA and client audits; draft or provide guidance for internal audit reports; contribute towards CAPA closure.
- Evaluation of Quality Assurance Operations processes to identify opportunities for continuous improvement. Lead and participate in the Continuous Improvement Program.
- Assess headcount requirements, adjust to business needs and monitor work schedules of staff based on operational activity and long range planning to ensure packaging and compliance requirements are satisfied.
- Conduct department investigations to determining the root/assignable cause for material and/or process nonconformance. These investigations shall be documented within applicable records. Interface with production personnel to assure appropriate and timely documentation of activities and assisting in resolving issues.
- Conduct periodic audits of the warehousing and packaging areas to assure that procedures are being followed and areas being maintained in a state of control.
- A bachelors degree in Science, Engineering, or Pharmacy is preferred and/or a combination of relevant education and experience.
- 8-10 years Quality Assurance experience. Three to five (3 to 5) years managerial experience in a Quality Assurance role in QA/Operations (packaging) is required.
- Pharmaceutical industry experience (Oral Solid Dose) is required.
- Experience in auditing and FDA/client inspections.
- Thorough knowledge of the cGMP requirements.
- Knowledge / experience in DEA procedures for controlled substances is preferred.
- Excellent verbal, written, and interpersonal communications skills.
- Working knowledge of computer applications (Word, Excel, Access, TrackWise, SAP etc.).
- Uses sound judgment to make good decisions based on information gathered and analyzed.
- Plans and organizes tasks and work responsibilities to achieve objectives.