Quality Assurance Associate

POSTED: March 11, 2019
BUSINESS: Purdue GMP Center
POSITION TYPE: Full-time 
START DATE: Immediate Availability

Essential Functions:

  • Perform all assigned duties according to established Quality Standards and Policy, Procedures, and Work Instructions.
  • Function as an advocate and ambassador for quality in all tasks and assignments.
  • Analytical Laboratory Support — Support functions for analytical testing may include, but are not limited to:  Review and assessment of in-process, release, stability and other testing data; Review method validation data; Review executed laboratory equipment validation protocols; Prepare and review product certificates of analysis; Generation and review of environmental chamber monitoring reports
  • Manufacturing Support — Support functions for manufacturing activities may include, but are not limited to:  Line clearances; Review and disposition of raw material specifications and testing/inspections; Review of draft and executed batch records; Review of environmental monitoring data; Review/approval of GMP warehouse temperature charts for refrigerators, freezers and temperature/humidity charts for the warehouse itself; Review manufacturing batch records for adherence to Good Documentation Practices (GDP) and verification of all calculations for accuracy
  • Equipment and Facilities Calibration, Maintenance, Validation, Preventive Maintenance — Responsibilities include, but are not limited to:  Ensuring that the GMP equipment tracking system is continuously updated and maintained; Monitoring completion of calibration, maintenance, PM, validation activities in advance of due dates; Review and approval of equipment documentation such as preventive maintenance plans, calibration plans and certificates, validation reports, and maintenance records; Ensuring that all new equipment and changes to equipment are documented on change control forms and approved by appropriate parties
  • Quality Systems — Responsibility to monitor and maintain 1 or more assigned quality system trackers and report periodic metrics from system to management; Independently review deviations and change controls for QA Management review and approval; Compilation and review of annual product quality reviews
  • Vendor Management — Interact with outside vendors to obtain regulatory documentation and vendor qualification information; Schedule external audits; Ensure proper maintenance of vendor-related documentation
  • Document Control — Support functions for Document Control include, but are not limited to:  Issuance of QA assigned numbers; Creation and issuance of logbooks; Routing and tracking of new and revised documents for approval; Filing of controlled documents and other documentation provided to QA, and ensuring that all documents follow the change control procedure; Communication with clients for review and approval of controlled documents; Author and revise assigned documents such as SOPs, component specifications, forms, and others.
  • Internal Audits and Client / Regulatory Audits — Support functions include, but are not limited to:  Participate as team member on assigned internal audits; Authoring of audit observations; Coordinating with audited department personnel on corrective actions; Finalization and close out of audit reports; Client and Regulatory audit functions include Facility tours, Retrieval of GMP documentation, and Implementation of corrective actions (as needed)

Additional Responsibilities:

  • Training of personnel on SOPs, remediation topics, and other training needs; review and archive training records
  • Prepare documentation, protocols and reports and provide recommendations for the QA unit
  • Assist in authoring and/or finalizing protocols provided by third parties
  • Act as Quality Assurance documentation liaison with the analytical and manufacturing researchers
  • Assist team members with other documentation efforts as necessary

Education/Experience

  • Bachelor’s degree in Health sciences related field (Chemistry, Biology, Pharmacy, Pharmaceutical Technology) is preferred
  • 0 – 4 years.  Experience (employment or internship) within the US pharmaceutical industry or laboratory experience considered a plus

Knowledge/Skills/Abilities:

  • Awareness of a variety of the pharmaceutical industry’s concepts, practices, and procedures, and the regulatory framework within which the pharmaceutical industry operates
  • Working knowledge of QC Laboratory Operations and common laboratory instrumentation a plus
  • Strong oral and written communications skills
  • Good organizational skills
  • Good analytical and investigative reasoning and critical thinking skills
  • The ability to work independently with minimal supervision, interact with staff (at all levels) in a fast-paced environment, sometimes under pressure, remaining flexible, proactive, resourceful and efficient, with a high level of professionalism
  • Proficiency in Microsoft Word, Excel, and PowerPoint
  • Favorable security (DEA/FBI/criminal) check and negative controlled substance test
  • Regular and reliable attendance is a requirement of this position

Application Instructions:

Interested candidates please send your cover letter and resume to careers@gmpcenter.com

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