QA Associate: Drug Substance - Cook Pharmica
Cook Medical - Bloomington, IN

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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 support the quality function by overseeing GMP activities, documentation and reports.

• To support the quality function with either a focus area of drug substance, drug product or systems.
• Review documentation for accuracy and compliance to procedures

• Maintain quality assurance programs, processes and facilities by ensuring compliance with regulatory, internal and client requirements in the manufacture of products

• Review and approve SOPs, change management requests and change controls for quality impact and compliance

• Review and approve item masters and product specifications

• Perform technical and administrative review of batch and analytical data for accuracy and compliance to procedures for raw material, in-process and product release
• Review and approve QC product testing documentation supporting batch release

• Perform and manage exception report, corrective and preventive action, and batch record review

• Review and approve level II exception reports

• Perform and document CAPA effectiveness checks

• Participate in internal or external audits as needed

• Create cGMP training sessions to be delivered to company employees in areas such as GMP Documentation Practices
• 2-4 years experience in a GMP/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

• BA degree required, Life Sciences specialization preferred, or equivalent work experience

• Previous experience in technical review of records preferred

• Required to sign a confidentiality and a non-compete agreement

• Ability to effectively communicate with co-workers as well as management

• Ability to work independently and in a team environment
• Ability to work at a computer desk setting for majority of the day

• 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

• Ability to gown in to area requiring clean room attire

• Potentially limited exposure to hazardous chemicals while in manufacturing environment

• Requires an eye exam if performing inspections (corrected 20/20 vision necessary)

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.

About this company
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Belonging to the Cook Medical division of the Cook Group, Cook Incorporated makes thousands of medical devices and related items. Its...