Quality Systems Analyst I

Quality Systems Analyst I

Requirements

• Bachelor’s degree from an accredited four-year college or university is required.
• Minimum 0-2 years of industry related experience is required with a Bachelor’s degree; or equivalent combination of education and experience with minimum 10 years of Quality experience.
• Pharmaceutical, medical device and/or manufacturing industry experience is required.

Responsibilities

• Responsible for providing guidance and feedback to both internal and external customers to ensure Quality Systems requirements are met.
• Support site documentation management program including implementation and obsoleting of documentation as a D2 systems coordinator.
• Review of Change Controls to include facilitating change control records and their associated action items for implementation and closure.
• Support computerized system audit trail reviews.
• Support site and Global TrackWise systems as Superuser.
• Assist in the drafting of annual product reports.
• Assist in the drafting of complaint trending reports.
• Review of Quarterly Quality Control trending reports.
• Review of equipment and cleaning validation protocols and reports.
• Support drafting, routing, and approval of executed Confidential Disclosure Agreements and Quality Agreements.
• Issuance of documentation and logbooks for product manufacturing, packaging, and testing.
• Support review and approval of calibration certifications, out of tolerance assessments (OOT) and/or OOT deviations.
• Provide support for maintaining weekly/monthly internal Quality metrics.
• Support internal, client, and regulatory audit requests as required.
• Within area of responsibility, understand and comply with all safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state, and local regulations.
• Perform other duties as assigned.

Preferred Qualifications

No preferred qualifications provided.