Quality Assurance Associate

POSTED: February 7, 2018

BUSINESS: Purdue GMP Center

POSITION TYPE: Full-time 

START DATE: Immediate Availability

Essential Functions:

  • Provide support for Quality System management and Quality Operations. 
  • Manage QA procedures and apply sound Quality-System improvements.
  • Perform batch record reviews and product dispositions.
  • Assess GMP suppliers and service providers. 

 Additional Responsibilities:

  • Review and approve SOPs, forms, manufacturing records, quality control records, and other documents.
  • Review and approve stability protocols per internal procedure, ICH, or post approval commitment requirements.
  • Review and approve stability data generated internally or externally (including identification of trend).
  • Analyze and report product and process quality trends, and quality system performance against internal and external guidelines, standards and regulations.
  • Follow up with functional department for timely completion of corrective/preventive actions and recommendations.
  • Manage, evaluate, and approve Quality System documentation including deviations (such as OOS), CAPAs, and change controls.
  • May serve as the quality operational technical representative on project teams evaluating new documentation processes or systems.
  • Collaborate with Manufacturing and Analytical Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve minor and major deviations.
  • Participate in cGMP compliance audits of suppliers’ quality systems.
  • Perform QA oversight activities to ensure required quality standards are maintained.
  • Liaise with Regulatory Affairs on any method/specification changes that may impact regulatory filings.
  • Prepare trend reports related to manufacturing process performances, deviations, test method performances and laboratory deviations.
  • Work internal and external projects in the quality review and approval of analytical methods, method validation protocols, and reports including revisions and associated change controls.
  • Work on internal and external projects in the quality review and approval of specifications, including justifications for specifications and subsequent revisions to specifications.
  • Support and conduct training for employees, as necessary.
  • Support Document Control related processes.
  • Other duties as assigned.

 Education/Experience:

  • Bachelors’ or higher degree in health-related sciences (chemistry, pharmacy, biology, nutrition, food science, etc.)
  • 3+ years of experience in a GMP environment.
  • Some experience in manufacturing of drug substances or drug products a plus.

 Knowledge/Skills/Abilities

  • Knowledge of GMP regulations and guidance (such as US, EU, and ICH).
  • Experience with Quality Assurance systems and processes.
  • Effective organization and planning skills.
  • Demonstrated ability to deal with frequent changes, delays or unexpected events.
  • Strong technical writing skills.
  • Advanced software skills (including SharePoint, Microsoft Office, and Acrobat Pro) and demonstrated troubleshooting and problem-solving techniques.
  • Strategic planning, leadership, and negotiation skills and the ability to develop and present training materials to large groups.
  • Ability to work under tight deadlines and pressure in a composed manner.
  • Effective interpersonal and communication skills.
  • Strong team player.
  • Comfortable communicating with all levels of staff, including executives.

APPLICATION INSTRUCTIONS:

Interested candidates, please submit cover letter and resume to humanresources@prf.org.

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