Cook Pharmica is a biopharmaceutical contract development and manufacturing organization (CDMO) with process development, clinical and commercial bulk drug substance manufacturing, formulation development, clinical and commercial parenteral drug product manufacturing, including liquid and lyophilized vials, prefilled syringes and secondary packaging, and an array of support services all at a single facility in Bloomington, IN. Founded in 2004, Cook Pharmica is a division of Cook Medical, the world's largest privately held medical manufacturing company.
To provide general and directed support of all Quality Assurance System functions and programs and to support the quality function by overseeing CGMP activities, processes, and projects.
Essential Job Function/Duties
• Participate in and support internal, client, regulatory or external audits to ensure the operations of all functional groups that affect SISPQ are in compliance with regulations, SOPs, policies and practices of Cook Pharmica LLC related to CGMP activities
• Maintain quality assurance programs, processes, and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products
• As required, review and approve change requests (SOPs, forms, etc.) and change controls for quality impact and compliance
• As required, preview approve item masters and product specifications
• As required, perform and manage deviations (NTR, Level I/II), corrective and preventive actions, and non-conforming material review and approvals
• As required, perform and document CAPA effectiveness checks
• Participate in internal or external audits as needed
• Must work and interact effectively with and for others to achieve company goals
• Must strictly adhere to safety requirements
• Must meet company attendance requirements
• Must maintain company quality and quantity standards
• Must have effective oral and written communications throughout various levels of the organization
• Ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
Minimum Work Experience/Education Requirements
• BA or BS degree required, Life Sciences specialization preferred, or equivalent work experience
• Previous experience in technical review of records preferred
• 2-4 years of experience in a CGMP/ISO environment preferred
• Have the written skills to accurately complete paperwork
• Excellent attention to detail
• Basic understanding of applicable regulations
• Knowledge of Good Manufacturing Practices applications
• Good organizational skills
• Basic computer entry/retrieval skills
• Ability to effectively communicate with co-workers as well as management
• Ability to work independently and in a team environment
Physical Requirements/Work Environment
• Must be able to lift/push/pull up to 30 pounds occasionally
• Ability to work at a computer desk setting for majority of the day
• Potentially limited exposure to hazardous chemicals while in manufacturing environment
• Personal protective equipment including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes may be required in areas associated with this position
• While performing Vendor Audits, this position may require 50-75% travel for domestic and occasional international travel.
We are proud to be an EEO/AA employer M/F/D/V. We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...