OneTrust

QA Associate III

OneTrust

full-time

Posted on:

Location Type: Hybrid

Location: Malvern • Pennsylvania • United States

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About the role

  • Provide end to end quality oversight of GMP R&D GxP laboratories responsible for analytical testing of commercial and clinical products in the biotherapeutics product portfolio.
  • Act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance.
  • Champion increased awareness of quality related concerns.
  • Partner with Research & Development and Supply Chain teams to support platform analytical method qualification, validation, and transfer to facilitate analysis of pre-clinical, clinical, and commercial products.
  • Collaborate with business partners to support process development studies.
  • Perform regularly scheduled oversight of R&D GxP laboratories.
  • Review and approve raw material and critical reagent release for use across the Janssen global network.
  • Review and approve controlled documents including standard operating procedures, work instructions, validation protocols and reports, and technical studies.
  • Ensure all non-conformances are fully investigated and effective corrective/preventive actions are implemented in a timely manner.
  • Support change management processes including formal change controls by evaluating the proposed changes, assessing impact, and providing quality input on implementation plans.
  • Provide quality oversight of the analytical instrument lifecycle management process, including new instrument qualification, equipment releases, corrective and preventative maintenance and calibrations.
  • Ensure data integrity and maintain compliance with general laboratory operations, all appropriate SOPs for laboratory work, data recording, and laboratory equipment.
  • Lead in process improvement activities including assessing current processes, providing improvement input and working with partners to implement changes.
  • Support site inspections and inspection readiness activities.
  • Ensure the laboratories are audit ready.
  • Support data integrity efforts.

Requirements

  • A minimum of a Bachelor’s Degree is required, preferably in Engineering, Biology, Biochemistry, Microbiology, Chemistry, or relevant scientific field/equivalent technical field.
  • At least 4 years of experience in a regulated manufacturing environment, preferably in biotechnology or pharmaceutical industry, is required.
  • Ability to maintain written records of work performed in paper-based and computerized quality systems.
  • Ability to work independently on complex issues with minimal supervision.
  • Ability to be organized and capable of working in a team environment with a positive demeanor.
  • A high degree of accuracy and attention to detail, and excellent interpersonal, oral and written communication skills.
  • Solid Understanding of cGMP regulations and FDA/EU guidance related to biologics or advanced therapies is required.
  • Experience in automated laboratory systems and warehouse/raw material sampling and receipt preferred.
  • Experience with quality support in clinical/GMP manufacturing or support of GXP laboratories is preferred.
  • Working knowledge of GLP regulations preferred.
  • Experience working with CMMS Systems like SAP and Maximo, and electronic laboratory notebook systems (Biovia, eLIMS) is preferred.
  • Experience performing and leading quality risk assessments for business processes is preferred.
  • Experience with document reviews and regulatory inspection processes is preferred.
  • Ability to prioritize daily business needs while being flexible and adaptable to frequently shifting priorities.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
GMPGxPanalytical testingmethod qualificationmethod validationdata integrityquality risk assessmentsdocument reviewsregulatory inspection processesprocess improvement
Soft Skills
interpersonal skillsoral communicationwritten communicationorganizational skillsattention to detailindependent workteam collaborationpositive demeanorflexibilityadaptability