Quality Assurance Analyst

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 laboratory testing support may include, but are not limited to:  Review and approve in-process, release, stability and other testing data; Review and approve method validation data; Review and approve executed laboratory equipment validation protocols; Prepare, review or approve product certificates of analysis; Generation, review, or approval of environmental chamber monitoring reports; Review and approval of method validation and equipment qualification protocols and packages
  • Manufacturing Support — Support functions for manufacturing activities may include, but are not limited to:  Line clearances; Review and approval of raw material specifications and testing/inspections; Review and approval of draft and executed batch records; Review and approval 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 assigned quality systems and report periodic metrics from systems to management; Present quality topics and contribute to Quality Council discussions when requested; Independently review deviations and change controls for QA Management review and approval; Serve as QA signatory or Management designee as assigned; Compilation and review of annual product quality reviews; Conduct and report quality investigations of deviations, OOS, Complaints, and other quality events; Tracks and manages the system for CAPAs, complaints, non-conformances, and investigations (to include classification of complaints, completion of investigations, and failure analyses with thorough and effective documentation and implementation of corrective actions (as needed)); Drive the timely implementation and closure of change controls while ensuring compliance to applicable quality standards and change-control procedures
  • Vendor Management — Interact with outside vendors to obtain regulatory documentation and vendor qualification information; Schedule external audits; Ensure proper maintenance of vendor-related documentation; Participate in external audits if assigned
  • 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; Serve as QA document approval signatory as assigned.
  • Internal Audits and Client / Regulatory Audits — Support functions include, but are not limited to: Lead and/or 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 conducting facility tours, retrieval of GMP documentation, presenting investigations or other quality content during audits and inspections.

Additional Responsibilities:

  • Support the preparation and execution of cleaning, process, computer, and method validation/verification documents and reports including determination and/or calculation of acceptance criteria
  • Perform and support maintenance and closure activities of documents such as reports, change controls, and protocol review
  • Ensure products meet approved company policies, process, and procedures
  • Review of process / product-related documentation
  • Responsible for interfacing primarily with technical, quality, and manufacturing groups
  • Generation and issuance of Quality Agreements 

Education/Experience:

  • Bachelor’s degree in science-related field is preferred
  • 3 – 6 years with at least 3 years’ experience in a quality assurance or quality control role in a cGMP regulated environment

Knowledge/Skills/Abilities:

  • Working knowledge of analytical laboratory operations and common laboratory instrumentation a plus
  • Exemplary oral and written communications skills
  • Strong attention to detail and excellent organizational skills
  • Excellent analytical and investigative skills and critical thinking
  • 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
  • Flexible and able to adapt to company growth and evolving responsibilities
  • Good teaching skills and ability to train others
  • Ability to analyze data/information and to assess and resolve complex issues, as required
  • Ability to work and communicate with cross-functional teams
  • Ability to manage multiple priorities and re-prioritize tasks, as required
  • 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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