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 support to the Quality Control laboratories by serving as the primary person responsible for receiving incoming QC samples from various manufacturing areas.
Essential Job Functions/Duties
• Retrieve and/or receive and process incoming QC samples in the LIMS
• Receive batch records from QA and/or Technical Services for testing
• Process completed batch records and return to QA
• Coordinate with QC Laboratory Services to send outsource samples for contract laboratory testing
• Coordinate stability sample retrieval with QC Stability
• Scan and file completed QC documents electronically
• Read, understand and follow SOPs pertaining to job functions
• Perform necessary functions to keep laboratory operations optimal
• Maintain training records and compliance
• Perform duties assigned in a quality and compliant manner consistent with regulatory requirements
• Perform routine laboratory calibrations on equipment to optimize laboratory operations.
• Must work and interact effectively with and for others to achieve
• 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/Educational Requirements
• Excellent attention to detail
• Ability to work in a team environment and interact with various management levels and groups
• Strong written and verbal communication skills to effectively communicate with co-workers as well as management
• Proficiency using Laboratory Information Management Systems (LIMS) is desired
• High school diploma or GED
• Required to sign a confidentiality agreement
• Experience in QC laboratory, microbiology, or the biotechnology industry is desired
Physical Requirements/Work Environment
• Majority of day spent in a standing position
• Able to identify safety and environmental hazards
• Must be able to lift/push/pull up to 50 pounds on an occasional basis
• Personal protective equipment including safety glasses, lab coat, gloves
Sign the confidentiality agreement. Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Cook Electronic Information Policy, and Cook Pharmica Quality Manual.
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...