Quality Associate II

Details:

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Description:

Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and quality practices.

Essential Duties and Responsibilities:

The incumbent will perform other duties assigned. Leads ongoing, daily departmental operations.

May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.

Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.

Work closely with production supervisors, quality, engineering and other internal groups to accomplish the above and influence necessary actions. Determine the logic, adequacy and effectiveness of processes, systems and related requirements.

Develop plans to correct identified risks including areas of non-conformance.

Inform management and implement approved corrective action plans. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements.

Provide training and coaching to local employees and others as needed in relevant area(s). When required, assist other Quality areas in the successful performance of these activities.

Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items.

Oversees audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.) Participate in QA/QC multi-site projects in the role of contributor, coordinator or lead. Other duties, tasks or projects assigned.

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