Quality Investigator - Pharmaceutical Manufacturing/Packaging (18-06-RFP09)

  • St. Louis, St. Louis, MO, us
  • Contract

Company Description

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.

Job Description

CP is seeking 2 Contingent Worker Quality Investigators for a 6-12 month assignment to work onsite at our pharmaceutical/medical device client located in  in St. Louis, MO.  

Provider to supply 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.

Status Meetings and Reports:

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.

Deliverables:

  • Investigate, write and close out all investigations in accordance with the client & FDA & GMP standards; throughout the Provider's engagement while adhering to the client and cGMP standards within a 30 day time frame.
  • Implement necessary follow-up verification checks on investigation Corrective and Preventive Action (CAPA} items, closing them out throughout term of project.
  • 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.
  • 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.

Qualifications

Knowledge of the following areas are critical:

  • Candidates MUST SHOW ACCEPTABLE PROOF OF U.S. CITIZENSHIP / U.S. Lawful Permanent Resident Status and successfully complete a drug & background check
  • Whether local to St. Louis or traveling, must onsite every Monday morning (9:00am meeting) through Friday afternoon.
  • Must be willing to work overtime on occasion to close out investigations on time. 
  • Must be willing and able to do the investigations and write CAPAS; 
  • Root Cause Analysis/Investigations in an packaging & inspections manufacturing environment 
  • GMP Pharma experience
  • Manufacturing Packaging and Inspection – Investigations experience
  • GMP Pharma experience
  • Experience performing investigations in a Pharma environment
  • Experience writing CAPAs in a Pharma environment
  • Some knowledge of aseptic processing
  • Demonstrated problem solving skills

Helpful experience:

  • Quality Investigations and a FDA remediation/Combination Products pharmaceutical manufacturing environment
  • Ability to demonstrate analytical thinking skills
  • 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
  • Additional biology or microbiology experience
  • FDA Compliance and GMP experience

Additional Information

All your information will be kept confidential according to EEO guidelines.