Quality Assurance Engineer I

Organization
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.

Requirements: 
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.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.