- Supply qualified investigators, to provide guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all investigations, corrective and preventive actions (CAPA}.
- Work with the operations leadership team and Quality Assurance to facilitate the consistent and disciplined execution of the investigation system ensuring the completeness and comprehension of the investigations while determining the most probable root cause.
- Review and analyze CAPA effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence.
- In charge of daily/weekly reports to management.
- Investigate, write and close out root cause investigations/CAPAs.
- Implement necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items closing them out throughout term of project.
- Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations regularly throughout term of project.
- Review Company's SOPs related to the quality investigational system and assist with improvement/revisions in a timely manner throughout term of project.
- Attend any investigational related meetings.
- Daily reports to Company as required.
- Weekly progress reports will be supplied to Company management outlining all activities, current status and estimated completion dates, unless otherwise directed by Company.
- Investigate, write and close out all investigations in accordance with company & FDA & GMP standards; throughout the Provider's engagement while adhering to company and cGMP standards within a 30 day time frame.
- Investigate Root Cause, write and implement CAPAs and interact with necessary departments and people to get the job done.
- Must respond timely to deliver quality investigations and thorough CAPAs throughout the term of the project.
W2 ONLY!!! NO CORP TO CORP!
- Bachelor's degree is preferred.
- GMP Pharma experience is critical.
- Knowledge of aseptic processing in critical.
- 8 years of experience performing investigations in a Pharma environment is critical.
- 2+ years of experience doing investigations performed in an aseptic environment and in a Quality Investigation role is required.
- Experience w/ Aseptic Techniques, Manufacturing, GMP and FDA.
- Knowledge of the following areas are critical:
- Root Cause Analysis performed in an aseptic environment.
- Investigations performed in an aseptic environment.
- cGMP's both US and other countries.
- Manufacturing Environment, Processes and Intradepartmental Linkages.
- Demonstrated Problem Solving Skills.
- Experience writing CAPAs in a Pharma environment.
- Ability to demonstrate analytical thinking skills.
- Root Cause Analysis performed in an aseptic environment experience.
- cGMP's both US and other countries experience.
- Manufacturing Environment, Processes and Intradepartmental Linkages experience.
- Additional biology or microbiology experience is a plus.
- Environmental compliance is a plus.
- FDA Compliance and GMP experience.
High Performance Liquid Chromatography
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Since our inception in 1999, Townsend and Associates aims to be the staffing firm both clients and professionals turn to first. Our core competencies in project staffing and full time placements are being continuously improved to be the best in class. Our markets will be solely determined by our ability to consistently deliver unequalled service to our customers and candidates.
Staffing your company with qualified and talented professionals is both challenging and time-consuming. Our goal is to make sure we understand your needs and the needs of our candidates. We research, screen and interview our consultants and employees, so we can provide you with the industries finest talent. This is why more and more companies decide to partner with Townsend & Associates, Inc.
Townsend & Associates, Inc. offers you the opportunity to work with Fortune 1000, small and medium companies for full-time or contract positions. We work together with you and our clients to create an ideal match. We discuss your career objectives, talent, experience, and what you are looking for in a new job.
Our screening research is 2nd to none. By being thorough and straight forward, we cut through a lot of challenges that arise in many job searches. So whether it’s full-time or a contract position let Townsend & Associates simplify and enhance your journey. Not Ready To Apply?
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