Quality Systems Associate

SUMMARY

- Provides project support with current Good Manufacturing Practices to clinical supply packaging operations.
- Provides guidance on procedures and training necessary to be in complete compliance with current GMPs.

RESPONSIBILITIES

- Change Management Process Owner - the QSS is accountable for overall management and coordination of the Site Change Management process. This includes the role as Compliance Network Member for changes affecting regulatory filings.
- Supplier Quality Management Process Owner - this role will also coordinate with Procurement to select and approve new suppliers and will support the ongoing monitoring program.
- QASA (Quality Assurance Self Appraisals) Team Leader - in this role, the QSS will lead the QASA Team and conduct QASAs to ensure objectivity and impartiality of the QASA process.
- APRR (Annual Product Records Review) Team Leader - the QSS will coordinate with the team to prepare an annual report to evaluate data and trending to verify the consistency of the process, identify the need to modify specifications or to implement corrective or preventive actions to lead to product quality improvements.
- This role will manage the system for change controls as well as coordinating with the team to evaluate proposed changes affecting regulatory filings and determine if Product Change Proposal or Request (PCP or PCR) are needed.
- They will create the PCP or PCR and gather the available information that supports the change proposal.
- Supplier Quality Management Process Owner -support the ongoing monitoring program by ensuring the performance of periodic GMP audits of suppliers, maintaining the approved supplier list, and performing and documenting supplier risk assessments.
- QASA (Quality Assurance Self Appraisals) Team Leader -The leader will prepare and issue the planned appraisal to assure the effectiveness of on-going quality systems, practices, and programs and to identify potential procedural gaps or system weakness.
- The leader will draft the QASA report and provide progress reports on corrective actions to any findings.

SKILLS:

EDUCATION AND EXPERIENCE

- A BS preferably in a scientific or engineering discipline.

TECHNICAL SKILLS REQUIREMENTS

- Strong analytical skills in collecting and researching data; capable of analysing information skillfully and maintaining accurate/concise records with attention to details.
- Skilled in mathematical reasoning, knowledge of probability and statistics and ability to use various applications such as Microsoft Access, Excel,able to express complex ideas in a clear, concise manner; capable of explaining technical issues to non-technical personnel.
- Writes clear, accurate and concise technical and non-technical documents.
- Capable of interfacing with management and non-management employees in manufacturing, engineering and maintenance, quality and laboratories.
- A candidate with experience with structured continuous improvement methodologies and risk management tools is desirable.
- Experience in GMP auditing is preferred but not required.
- MS Excel