Description
A key client of ours is looking for a Quality Assurance QA Specialist III. This position is a 6 month temp-to-hire role.Ideally this candidate needs QA experience (not QC/lab focused), biotech experience, experience working night shift or 12 hour shifts. Shifts are 12 hours and rotate every two weeks to include weekends.
QA Quality Assurance Specialist III Responsibilities Include:
-Assuring the quality of products manufactured at the facility.
-Performs on the floor inspections of the production areas to resolve issues early and to ensure compliance with SOP and regulatory requirements
-Supports functional areas including manufacturing, facilities, and other Quality departments.
-Implements quality policies for process improvements, manages quality systems, and assists in facilitating regulatory compliance inspections.
-Utilizes Quality Systems in compliance with current good manufacturing practices. Maintains database, generates routine reports.
-Supports the evaluation and lot disposition of intermediates and finished products through timely review of batch records, laboratory results and other GMP documents.
- Investigates and assesses the impact of minor and major deviations that may occur during manufacture, testing or distribution of products. Identifies root causes, recommends and implements corrective actions to prevent recurrences.
- Employs metrics to track performance of operations and quality systems.
- Performs trend analysis to monitor process and facility performance. Reviews, assesses and approves change control and NC and corrective action. Interprets complex data and ensures compliance with specifications.
- Understands application of validated systems and functionality of their use in Quality Systems. Works under only general direction.
-Independently determines and develops approach to solutions.
-Work is reviewed upon completion for adequacy, in meeting objectives.
-Contributes to the completion of specific programs and projects.
- Frequent inter-organizational and outside customer contacts.
-Represents the organization in providing solutions to difficult technical issues associated with specific projects.
Requirements
5-7 yrs of QA experience.
Prior night shift experience is desirable, prior biotech experience preferred
Bachelors in Sciences
Experience with Trackwise, SAP and Aegis is desirable. Prior biotech experience is preferred.
Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organizational objectives. Good understanding and wide application of technical principles, theories, and concepts in the field. General knowledge of other related disciplines. Experience with Trackwise, SAP and Aegis is desirable. Prior biotech experience is preferred.