Quality Investigator-Aseptic Manufacturer (18-06-RFP09)
- St. Louis, St. Louis, MO
CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Engineering headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.
CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.
CP is immediately seeking for our St. Louis based client two (2) Local Contingent Worker to perform as a Quality Investigator-Aseptics Manufacturer for a 6-12 month initial assignment.
CP is seeking 2 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). The investigators will 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. The investigator will review and analyze CAPA effectiveness through appropriate tracking and trending methods in order to prevent reoccurrence. Investigators are also in charge of daily/weekly reports to management.
Scope; Activities, Tasks:
- Investigators will perform the following activities:
- Investigate, write and close out root cause investigations/CAPAs.
- Implement necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items
- Coach Company colleagues to facilitate a focused knowledge transfer regarding quality investigations
- Review Company's SOPs related to the quality investigational system and assist with improvement/revisions
- Attend any investigational related meetings.
- Candidates MUST SHOW ACCEPTABLE PROOF OF U.S. CITIZENSHIP / U.S. Lawful Permanent Resident Status and successfully complete a drug & background check
- Proficient in English
- Root Cause Analysis/Investigations in an aseptic manufacturing environment – must have a minimum of 4+ years
- GMP Pharma experience – 7+ years
- Experience performing investigations in a Pharma environment – 7+ years
- Additional significant microbiology experience and education – 4+ years
- Experience writing CAPAs in a Pharma environment – 7+ years
- Demonstrated problem solving skills – 15+ years
- Quality Investigations and a FDA remediation/Combination Products pharmaceutical manufacturing environment
- Ability to demonstrate analytical thinking skills
- cGMP's both US and other countries
- Manufacturing Environment, Processes and Intradepartmental Linkages
- FDA Compliance and GMP experience
All your information will be kept confidential according to EEO guidelines.