QA Associate, Drug Product - Cook Pharmica
Cook Medical - Bloomington, IN

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PRINCIPAL DUTIES AND RESPONSIBILITIES:
Essential Functions:
  • 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
Additional Responsibilities:
  • Provide continuous cGMP training to company employees in areas such as GMP Documentation Practices
  • Track and trend quality metrics, CAPA, PPQE
  • Identify and report possible exceptions to SOP’s
  • Support AQL’s for inspection
AUTHORITIES:
  • Identify and report possible exceptions to SOP’s
  • Identify and report possible preventive and corrective actions
  • Identify potential hazards either safety or ergonomic
  • Identify and report safety and environmental hazards
  • Review and approve item masters and product specifications
EMPLOYMENT REQUIREMENTS:
  • 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
POSITION QUALIFICATIONS:
  • 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
  • Ability to effectively communicate with co-workers as well as management
  • Ability to work independently and in a team environment
ACCOUNTABILITY:
  • Responsible for completing assigned tasks by due dates
  • Responsible for compliance to company’s Quality Policy Manual
  • Responsible for compliance with company’s safety policies
  • Responsible for knowing and adhering to policies and procedures in the company’s Employee Handbook
  • Responsible for compliance of Corporate Code of Conduct
PHYSICAL REQUIREMENTS AND ENVIRONMENTAL CONDITIONS:
  • 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
  • Potentially limited exposure to hazardous chemicals while in manufacturing environment
  • Ability to gown in to area requiring clean room attire
  • 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.

Cook Medical - 2 years ago - save job
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...