Associate II, IPQA 2ND Shift - ReqCode 92381BR

Sandoz, a global leader in the rapidly growing generics industry, is a company in which doctors, pharmacists and patients worldwide have placed their trust for more than 100 years. With our 23,000-plus employees in more than 130 countries, we save and improve lives by developing, producing and distributing high-quality, affordable pharmaceuticals. Choosing Sandoz is always 'a healthy decision'. Through our work and our medicines, we have committed ourselves to improving the quality of life of people the world over. Our future holds many opportunities. Let's explore them together!

Job Description:SUMMARY

The Manufacturing In-Process Quality Assurance Associate (IPQA) will focus on initial deviation investigative phases related to manufacturing process deviation. Specific responsibilities will be responding to manufacturing calls for assistance, documentation and immediate corrective action associated with these deviations. IPQA associates are responsible for responding to customer needs immediately, ensuring appropriate corrective action is taken and process controls are in place. IPQA associates work closely with Quality Engineers and QA Management to ensure thorough and complete investigation activities. The IPQA Associate is responsible for the receipt, documentation, evaluation, follow-up and investigation of all technical product complaints for Sandoz drug products. Carries out all responsibilities in accordance with Sandoz policies and procedures as well as state, local and federal laws.

RESPONSIBILITIES

* Responsible for identifying deviations in the processes that ensure all activities are cGMP compliant, identifying corrective actions, establishing path forward activities, and appropriate documentation is complete.

* Facilitates use of existing management processes regarding deviations, investigations, and preventative actions.

* Ensure compliance with SOPs, Policies and Procedures as required by Sandoz and regulatory agencies

* Performs area assessments and ensures compliance in all activities with cGMPs and Compliance activities

* Identifies deviations in processes and initiates corrective actions

* Administration and management of deviations/investigation/PAC systems in Trackwise

* Control materials for compliance purposes in SAP

* Actively involved with Investigation Review Board. Individuals will be required to maintain responsibility for management of specific process

* May be asked to perform QA sampling duties as required

* Maintains active communication with customers to facilitate continuous process improvement. Other duties as assigned.

SUPERVISORY

* This position has no supervisory responsibility.

**Working Hours**
2:00 pm to 10:30 pm or
3:00 pm to 11:30 pm (rotating)
Minimum Requirements:Two year Associates Degree required
BS or BA degree in a Chemistry, Science or Engineering field preferred.
Minumum 2 years QA/QC experience. cGMP experience required. Trackwise/SAP experience a plus. Pharmaceutical manufacturing experience a plus.

Adherence to all health, safety & environmental requirements in support of departmental and site HSE goals.
Work in a safe and efficient manner.