Quality Assurance Analyst

Description

Must be able to work 3rd shift role, four ten hour days. Sun to Wed 9:30pmEST to 8:00AMEST or Wed to Sat: 9:30pmEST to 8:00AMEST

QA Shop Floor - 3rd shift

Must be able to work four 10 hour days

Sun to Wed 9:30pmEST to 8:00AMEST

or

Wed to Sat: 9:30pmEST to 8:00AMEST

• 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: (Define key accountabilities and/or activities.)

• 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.

Quality Assurance and Compliance Focus

• Provides daily ‘Shop Floor” QA support to warehouse, bulk manufacturing and packaging lines.
• Provides leadership support to QA Shop Floor activities including communication of quality events to management.
• Performs or supports activities related to Batch Record Review, Raw Material, Bulk, and Finished Product Releases.

Performs other related duties as required.