Quality Assurance Specialist I

Objectives/Purpose of Job:

The role of Quality Assurance Specialist I is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Assurance Specialist I may be involved in all stages of the product life cycle - Product design, manufacturing support, and post-launch maintenance.

Key Activities:

• Participates in efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.
• Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Management of nonconformances for assigned areas of QA oversight. Assist/perform failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions. Execute CAPA effectiveness verifications to confirm that the corrective actions implemented are effective.
• Trending of key quality metrics, including nonconformances. Preparation of trend reports and presentations for management. Evaluate metrics to identify areas of potential process improvement. Assist in implementation of process improvements.
• Quality oversight of validation activities for assigned areas of oversight, including QA review and approval of validation documentation.
• Create and revise quality related documentation. Review and approval of operations records for assigned areas of quality oversight.
• Familiarity with sterile or Aseptic Manufacturing.

Qualifications:

• Bachelor's degree (BA/BS) in life sciences, physical sciences, engineering, or a related field is required.
• Certifications preferred: CQA, CQE, and CQM.
• Experience in Quality Assurance or Quality Control within pharmaceutical or medical device manufacturing.
• Familiarity with 21 CFR 210, 211, and/or 820 and ISO 13485.
• Strong understanding of GMPs and regulated quality systems Experience:
• Experience with nonconformance investigations and root cause analysis preferred Ability to trend, analyze, and graph data for presentation to management

Special Skills:

• Detail-oriented and well-organized
• Ability to multi-task and effectively shift priorities as needed to meet operational requirements and customer demand