Quality Assurance Associate

Position Summary:

This role is responsible for administrative and project based tasks within the Quality Assurance department. The Quality Assurance Associate role is pivotal in the daily functions of the Quality operation within a growing organization and meticulous attention to detail is a key to success in this role. The Quality Assurance Associate is primarily responsible for the Batch Record Review and Document Control processes at Stratacuity. This position is a full-time, non-exempt role that reports to Quality Management.

Areas of Responsibility:

• Review of batch production records for completeness and release
• Review of analytical records and any supporting documentation to ensure compliance with cGMPs and LGC Biosearch policies and procedures.
• Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations.
• Perform routine document control activities including creation and/or revision, processing, routing and review.
• Work with various departments to set up appropriate documentation to improve efficiency and accuracy.
• Assists in performing QC data review for batch record in-process and final QC approval.
• Assist with internal Quality audits of internal departments, as necessary.
• Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance.
• May be called upon to assist with the Supplier Qualification program.
• Provide guidance and train others on Quality System and Quality Assurance procedures.
• Perform additional tasks, as assigned
• Experience with Batch Record Review, Product Disposition and Document Control.
• Familiarity with ISO 9001:2008, ISO 13485:2003 and 21 CFR 820.
• Excellent people, verbal, and communication skills.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  The requirements listed below are representative of the knowledge, skill, and/or ability required.

Must have solid teamwork skills to interface with engineers, chemists, technicians and analysts to ensure smooth laboratory and plant operations.

Self-motivated individual who can work in a multi-disciplinary team.

Good troubleshooting, communications, and teamwork.

Education/Experience:

• Bachelor’s degree