Quality Assurance Director is responsible for the implementation of policies and procedures to ensure adherence to production quality standards. Monitors and audits process, material, and product testing against established standards and conducts a continuous analysis of quality defects and deviations. Being a Quality Assurance Director identifies deficiencies or gaps in testing activities and develops solutions to ensure adequate and robust quality processes. Optimizes processes to comply with existing and new regulatory requirements. Additionally, Quality Assurance Director typically requires a bachelor's degree. Typically reports to a director. The Quality Assurance Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Quality Assurance Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
This QA Associate III – Analytical position is an individual contributor role and is a member of InvaGen’s QA Team at the Fall River, MA (Unit IV) site. The position reports to the Site QA Lead. The essential and typically expected job duties for this position include but are not limited to the following:
• Review data generated in the laboratory is accordance with stablished criteria set forth in SOPs and
established specifications
• Assemble quality data to support management review meeting requirements
• Issuing, reviewing, maintaining, and archiving of laboratory logbooks
• Scanning of laboratory approved finalized qualification for easy accessibility by all department
• Training and execution of internal audits, as required
• Review/approval of calibration records for analytical instrumentation and equipment
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Complete other duties or participate in project work as assigned by management.
• Minimum bachelor’s degree from an accredited college/university in relevant field of study such as Chemistry,
Pharmaceutical Science, or other Life Science discipline.
• Advanced training or education in pharmaceutical quality compliance or related field of study from an
accredited college/university.is preferred.
• Minimum of three (3) years’ experience in quality assurance in a current Good Manufacturing Practice (cGMP)
pharmaceutical work environment.
• Experience in metered dose inhalation (MDI) preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP,
and other business applications.
Job Type: Full-time
Salary: $70,354.60 - $85,620.59 per year
Benefits:
Schedule:
Experience:
Work Location: In person
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