Quality Assurance Coordinator - Collaborative Environment

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Job description

A quality assurance personnel is responsible for ensuring that products and services meet the established standards set by the company. Duties include maintaining strong overall quality control of products made by the company adhering to reliability, performance and customer expectation.

Qualifications
? Minimum of 3 years of pharmaceutical industry experience directly related to QA/Regulatory Compliance; working knowledge of cGMPs and FDA/ICH guidelines.
? Experience performing investigations and root cause analysis;
? Ability to write reports, business correspondence, and standard operating procedures
? Ability to effectively (diplomatically) present information and respond to questions from groups of managers, third party contractors and customers.
? Ability to understand and implement priorities and work load and to establish strong collaborative relationships with peers.
? Ability to work a flexible work schedule to accommodate program and project priorities as needed.
? Excellent written and verbal communication skills
? Previous direct experience working with electronic systems such as Veeva, TrackWise, SharePoint or similar software applications
? Excellent attention to detail, project and time management skills, and the ability to manage multiple priorities with aggressive timelines.
? Strong competency in MS Office product and Adobe Acrobat
? Ability to work effectively/congenially; both independently and with a multidisciplinary team.
? Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

Essential Duties and Responsibilities
? Collaborate with site operations for investigations and change controls.
? During investigation review ensure the execution is consistent with company policies, procedures, and regulatory filings.
? Provides monthly reconciliation and trending lists to management review board
? Perform unit trending in support of quarterly metrics reporting
? Partner with multiple cross-functional groups, including external contract service providers to drive process and product related improvements associated with confirmed complaint issues (as needed).
? Promote a culture that supports continuous improvement through active communication and functional area participation.

Other Duties
? Responsible for providing training as SME on investigations and change management process (as needed)
? Responsible for maintaining SOPs, Work Practices, Job Aids and training materials
? Support enhancements and upgrades to the QMS system and perform user acceptance testing
? Assist in the execution of the various QA systems including trending and information reporting
? Other duties, responsibilities and activities may be assigned. AppleOne is proud to be an Equal Opportunity Employer. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment qualified applicants with arrest and conviction records.

0-1 years