(Archived) Quality Control Technical Specialist

Position Summary

Provide technical guidance on issues/projects within the Quality Control (QC) department. Identify and drive continuous process improvements. Participate in or lead large scale investigations for Quality Control. Identify and implement cost savings initiatives for the site. Coordinate the engagement of the Manufacturing or Global Manufacturing Technology (GMT) organization as needed. Conducts all activities and makes decisions that are in accordance with Company policies & SOPs, Zoetis Values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.

Position Responsibilities

• Systematically review current QC assays for opportunity to remove variation and / or improve technology. Once identified, outline and execute project plans to refine or replace assays or assay steps.
• Take a lead in continuous improvement efforts. Be proficient in leading change, writing change control documents and managing /coordinating all aspects of project implementation.
• Participate or lead key site investigations through to completion. Partner with other departments to provide support as needed. Support may include data collection, study design, statistical analysis and study execution.
• Take the quality lead in the introduction of new processes or modifications to existing processes as supported by Global Manufacturing Technology (GMT). Assist in performing technical evaluations and implementation of GMT initiatives to ensure robust process improvements and transfers.
• Partner with OpEx in utilizing visual management and Lean Lab initiatives to identify and implement cost savings and improved laboratory and testing efficiencies. Lead the cost savings projects through to completion.
• Communicate and work with the Equipment Engineer and/or Maintenance on process improvements of existing equipment and identifying new equipment.
• Collaborate with area Team Leader to train and lead colleagues in the performance of best practices.
• May lead small projects and project teams.
• Prepares periodic project updates and participates in conference calls and meetings.
• Investigates identification and application of new technologies (innovation) as assigned.
• Supports execution of local and regional Quality method improvement activities.
• Supports regional and global program initiatives.

Education and Experience

• BA/BS with 2-4 years of experience OR MBA/MS with 0-2 years of experience OR Minimum of 8 years relevant experience. Bachelor’s Degree in relevant biological area (Microbiology, Virology, Immunology, Biological Systems Engineering, or related technical field).
• Knowledge of quality and regulatory requirements for developing and verifying QC methods.
• Must have strong technical/analytical skills and possess a high degree of personal motivation.
• Excellent interpersonal skills and ability to interact across divisional boundaries.

Technical Skills Requirements

• Strong technical writing skills.
• Experience preparing and interpreting basic statistical reports.
• A working knowledge of biological testing methods and experimental design and experience in GLP or cGMP.
• Method development and troubleshooting experience to include method and product investigations.
• Demonstrated ability to lead investigations by performing technical evaluation followed by implementation of initiatives to ensure robust process improvements.

Physical Position Requirements

• Physical Demands Include: Sitting, Writing, Typing, Talking, Hearing, Seeing, Lifting.
• Work Environment: While performing the duties of this job, the employee occasionally works in environments with extreme temperature (hot /cold) & humidity, with limited lighting and in crowded spaces. The noise of these work environments are typical office noises.