Quality Assurance Engineer I

Actavis, Inc.
Job Location
Corona, CA
Job Description

Summary: Under general supervision, assists in the generation and review of Annual Product Reviews. Assists in complaint investigations. Audits, monitors and trends assigned work for implementation of corrective and preventative measures. - Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws.

- Analyzes data from production and laboratories, compiles data for Annual Product Reviews.

- Monitors activities in assigned areas for compliance to standards and opportunities for improvement.

- Coordinates investigations into product complaints.

- Tracks Annual Product Review approval.

- Tracks complaint investigations and follow-up.

- Assists in compiling and generating quarterly and annual quality review documents.

- Researches and recommends improvements in production and laboratory systems.

- Complies with all Company policies and procedures, including safety rules and regulations. Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment.

- Performs related duties as assigned.

Knowledge of: - Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements in a regulated manufacturing environment.

- OSHA, FDA, EPA, AQMD and other applicable regulatory and safety compliance guidelines.

- Investigations to determine cause, corrective action and prevention planning.

- Applied cGMP's and Company systems.

- Laboratory equipment and testing.

- Auditing techniques in a regulated environment.

- Preparation and presentation of Annual Product Reviews (APR's).

- Compilation of data investigation of Product Complaints.

- Applied statistics and trend analysis.

- Pharmaceutical manufacturing, its customers, competition and market.

- Pharmaceutical manufacturing suppliers, raw materials and products.

- New and emerging inspection and test technology.

- English usage, spelling, grammar and punctuation.

- Engineering and business computer systems and software applications.

Skill in:

- Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.

- Analyzing and troubleshooting problems, identifying solutions, and recommending and implementing methods, procedures, systems and/or techniques for resolution.

- Writing clear and concise technical reports.

- Working with attention to detail, and independently with minimal supervision.

- Managing multiple projects.

- Communicating clearly and concisely, both orally and in writing.

- Establishing and maintaining effective working relationships with individuals contacted in the course of work.

- Utilizing a computer and standard business and engineering software.

Minimum Qualifications: Bachelor's Degree in Science, Engineering or related field from an accredited college or university, and zero (0) – one (1) year related experience preferably in a quality assurance environment; or, an equivalent combination of education and/or experience.

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