QA Associate Job in Elizabeth 07207, New Jersey US
Job ID: 272Position Description: Actavis is a leader in the development, manufacture and sale of first-class generic pharmaceuticals with operations in 32 countries, products registered in more than 60 countries, a robust development pipeline and an aggressive acquisition strategy.
Comply with the responsibilities of the QA Associate position for the Elizabeth Site while following cGMP and corporate policies to achieve company goals and initiatives.
Review and approval of cGMP related documentation for compliance such as master formulas and packaging records, validation and qualification protocols and reports (equipment, computer, process, etc), labeling, product specifications, and other documentation.
(70%)Develop and revise controlled documents and procedures pertinent to Quality Assurance (QA) activities and functions and conduct training for the associated documents.
(10%)Perform investigations and prepare associated reports for deviations related to QA. (10%)Perform and facilitate periodic audits related to QA documentation and systems.
(5%)Supports FDA and other regulatory compliance inspections including preparation and corrective actions as needed.
(3%)Ad hoc responsibilities as assigned by Management.
(2%)Report quality issues to Quality and Site Management.
Position Requirements: 3-5 years experience in Quality Assurance in an FDA GMP regulated environment.
Bachelors Degree requiredCurrent knowledge of QA solid oral dosage manufacturing, Documentation, Change Control, 21 CFR Parts 210 and 211, and cGMP's in the pharmaceutical industry.
Scientific background preferred.
Ability to interact with all levels of the organization.
Ability to foster and work in a team environment.
Experience using Microsoft Office applications (including Word and Excel) Trackwise, and QUMAS.
Ability to analyze data with demonstrated attention to detail.
Excellent written and verbal communication skills.
Team oriented including strong inter-personal skills with the ability to work independently and proactively.
Must be able to successfully interact with others and approach controversial issues in a balanced and diplomatic manner.
Must be able to work overtime as needed.ASQ Certified Auditor preferred.
Actavis offers a competitive salary and comprehensive benefits package to all eligible employees.
Actavis is an Equal Opportunity Employer and appreciates diversity in our workforce.
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