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Job Category:
Software Development
Employment Type:
Full time
Posted:
3/24/2012
Quality_In Process Quality Assurance (IPQA) Associate III/II
(This job is no longer available)
Novartis Pharmaceuticals | Broomfield, CO
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Job Description

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Job ID 91616BR
Posting Title Quality_In Process Quality Assurance (IPQA) Associate III/II
Division Sandoz
Business Unit Sandoz - Global Quality
Country USA
Work Location Broomfield, CO
Company/Legal Entity USA Sandoz Inc Princeton NJ
Functional Area Research
Job Type Full Time
Employment Type Permanent
Job Description Summary:

Multiple Shifts available among the openings.

Responsible for maintaining Quality Assurance presence in the production and laboratory
processes, ensuring that products, materials, batch records and labeling are properly
dispositioned according to internal and external regulations and standards (SOPs and cGMPs).
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. May be called upon
to complete specific project work such as process improvement/remediation, maintain
ownership and responsibility for specific QA processes. IPQA Associates III are expected to
function with a moderate level of oversite from Quality Engineers and limited oversite of
department manager. Carries out all responsibilities in accordance with Sandoz policies and
procedures as well as state, local and federal laws.

Responsibilities:
1) 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.
2) Facilitates use of existing management processes regarding deviations, investigations, and
preventative actions.
3) Ensure compliance with SOPs, Policies and Procedures as required by Sandoz and
regulatory agencies.
4) Performs area assessments and ensures compliance in all activities with cGMPs and
Compliance activities.
5) Administration and management of deviations/investigation/PAC systems in Trackwise.
6) Control materials for compliance purposes in SAP.
7) Actively involved with Investigation Review Board. Individuals will be required to maintain
responsibility for management of specific process.
8) May be asked to perform QA sampling duties as required.
9) Maintains active communication with customers to facilitate continuous process
improvement.
10) Receives little supervision for most assignments. Receives general instructions for nonstandard
analyses and projects. Data analysis is complex and requires input from multiple
sources and innovative problem-solving. Interfaces to negotiate and exchange information
with all levels of management.
Minimum requirements BA or BS degree in Chemistry, Science or Engineering field. Minumum 4 years QA/QC
experience. cGMP experience required. Trackwise/SAP experience a plus. Pharmaceutical
manufacturing experience a plus.

Maintains positive attitude and team focus. Requires skills in change management,
negotiation, conflict resolution and collaboration with others. Maintains high level of
professionalism and acts as a calming influence in all situations. Vigilent to ensure
compliance to cGMPs, site policies and procedures and regulatory requirements. Strong
verbal and written communication skills.

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

 

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