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.
- 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.