Lead Quality Investigator

Headquartered in Dublin, Ohio, Cardinal Health is a $75 billion, global company serving the healthcare industry with a broad portfolio of products and services. Through its diverse offerings, Cardinal Health delivers integrated healthcare solutions that help customers reduce their costs, improve efficiency and deliver better care to patients. The company manufactures, packages and distributes pharmaceuticals and medical supplies, offers a range of clinical services and develops automation products that improve the management and delivery of supplies and medication for hospitals, physician offices and pharmacies. Ranked No. 16 on the Fortune 500, Cardinal Health employs more than 55,000 people on six continents.

Position requires experience in the inspection/investigation process associated with receipt of purchased materials, and acceptance of drug product during various phases of the manufacturing and packaging processes as well as overall GMP inspection of all areas of the facility. Review in-process production documentation for completeness and accuracy to assure adherence to the FDA guidelines to support the manufacture and release of quality product.

Perform assigned inspection tasks, in accordance with cGMPs and all governing corporate procedures, as required for the following activities:
a. receiving inspection of purchased packaging components.
b. in-process inspection during drug product manfacturing.
c. in-process and finished goods inspection during product packaging.
d. generate documentation for submittal of samples and materials for laboratory
analysis.
Be able to set-up, calibrate as necessary, operate and clean all equipment required to perform the inspections listed above.
Perform issuance and receipt of materials associated with the Production Operation to assure accurate inventory records.
Assist in the training of all inspection personnel to assure that personnel are adequately trained to perform assigned inspection activities and support established Quality Systems.
Assess production schedules daily and acting in cooperation with Operations Management, assure Quality Compliance Input to support production demands.
Support the execution of validation protocols, ensuring documentation is accurate and complete to support the facility validation efforts.
Review batch records and associated documentation from completed production runs to ensure all required data, calculations, signatures, dates, etc., are present, correct and accurate prior to release to further processing, inventory and market.
Actively acquires and maintain a working knowledge of all Standard Operating Procedures and Department Operating Instructions that are applicable QA Inspection operations.
Performs investigations and documents findings utilizing established Failure Investigation and Deviation Report formats. Resolves daily quality issues, conduct root cause analysis.
Collects/analyzes/reports quality metrics in support of Global Harmonization of Quality Systems (CAPA, Change Control, Discrepancy Reporting and Customer Complaint Systems).
Other duties as assigned.

BS in Chemistry or science related field. Four to six years experience as a Quality Inspector or Investigator in the pharmaceutical industry.


Benefits:


Cardinal Health offers a competitive compensation and benefits package including 401K and tuition reimbursement. Successful candidates must pass a background check and drug screen. We are an Equal Opportunity Employer M/F/D/V - Diversity Works Here.