Analyst 2, Quality Assurance

Summary

The position is responsible for providing daily Quality Assurance support to the manufacturing site to ensure internal and regulatory cGMP and CFR requirements are met. Quality Assurance support areas include but are not limited to Batch Record Review, Product Release, Standard Operating Procedures, Investigations, CAPA, Change Control, Shop Floor Audits. The position will interact with other departments including Manufacturing, Packaging, Quality Laboratories, Quality Systems, Validation, Engineering, Maintenance and other departments as it relates to site Quality Assurance responsibilities.

Responsibilities

• Under limited supervision and in accordance with all applicable federal, state and local laws / regulations, the Companies' policies, procedures and guidelines, this position :
• Ensure quality and compliance in all my actions by : All employees :
• Attend GMP training on the schedule designated for my role and as appropriate for my role.
• Adhere to strict compliance with procedures applicable to my role.
• Exercise the highest level of integrity in the tasks that I perform.
• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.
• Embrace a behavior of employee involvement and commitment to doing the job right the first time. People Managers
• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.
• Promote an environment of employee involvement in the workplace.
• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

1. Quality Assurance and Compliance Focus

2. Customer and Performance Improvement Focus

3. People & Organization Focus

4. Performs other related duties as required.

What we are looking for Qualifications :