What are the responsibilities and job description for the Quality Assurance Analyst position at Katalyst Healthcares and Life Sciences?
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
- Attending GMP training on the schedule designated for my role and as appropriate for my role.
- I 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.
- Ensure employees under your Product of responsibility are trained in required procedures for the execution of their role and maintain current 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.
- Provides support to Investigations and / or Investigation Protocols, responsibilities include conducting, writing, reviewing and approvals.
- Performs or supports activities related to Line Audits, Line or Area Cleaning Verifications.
- Participates in design of quality processes and creation / modification / approval of Standard.
- Operating Procedures (SOP's).
- Provides support to Consumer Complaint investigations.
- Provide QA support to various project teams, as needed.
- Actively supports Site metrics, compliance improvement and training initiatives.
- Customer and Performance Improvement Focus.
- Provide support to capturing of site metrics and promote improvement opportunities.
- Facilitate resolution of issues to improve site metrics.
- People & Organization Focus.
- Provides training and direction as needed for new employees.
- Teams with Department members for process feedback and continuous improvement opportunities.
- Represents Quality Assurance in a positive manner.
- Performs other related duties as required.
Requirements :
