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Quality Control Analyst III Quality Control Analyst III
Ref No.: 18-06002
Location: Malvern, Pennsylvania
Site Quality Operations (SQO) department is a service unit supporting the Clinical Supplies organization.  It is responsible for providing Quality Assurance activities and services to the Clinical Supplies Platform in maintaining compliance with global and regional ICH/GCP and cGMP requirements.

Site Quality Operations (SQO) department is a service unit supporting the Clinical Supplies organization.  It is responsible for providing Quality Assurance activities and services to the Clinical Supplies Platform in maintaining compliance with global and regional ICH/GCP and cGMP requirements.
  • Monitor and continuously improve the Quality system by evaluating supporting documentation to ensure compliance to cGMP, Industry standards and other applicable regulations.  Take appropriate actions to correct any deficiencies found.
  • Perform inspection and release for investigational product labeling, investigational and commercial product and packaging components against approved specifications.
  • Perform routine inspections of retain samples and maintain up to date inventory of retain samples.
  • Review and approve labeling design and final proofs as well as printed packaging materials to ensure compliance with FDA and ICH regulations.
  • Perform batch record reviews for all Investigational Product labeled and packaged at Northborough (or contractor) as well as release for incoming product, components and labeling and packaging materials as needed.
  • Provide input, review and approve documentation for the labeling/packaging operations at contract vendors. Perform batch record review and release for these operations to ensure compliance to cGMP and other applicable regulations.
  • Assist in internal audits, as needed, and raise CAPAs in Trackwise or equivalent system, as needed.
  • Provide support and assist in managing Quality eSystems to ensure compliance to established timelines for deviations, CAPAs, investigations, OOS, etc.
  • Provide Quality support and services to Clinical Supplies, as needed, to ensure compliance to cGMP and other applicable regulations.
  • Complete other duties, tasks and projects as required.
 
Skills
 
  •  Experience in Clinical Supplies is a plus.
  • Quality Inspection experience is preferred
  • Experience in auditing, training, document/label design, change control, deviations and CAPAs, complaints and risk management
  • Knowledge of regulations and standards affecting Pharmaceuticals, Biologics, and/ or Medical Devices. 
  • Experience with GMP/GCP/ICH standards and regulatory guidance documents
  • Working knowledge of Trackwise, Phenix and Livelink a plus.
  • Good presentation skills, excellent written and verbal skills.
  • Experience with project management or project team leadership.
  • Experience generating process metrics and reports.
  • Scope
  • Clinical Supplies GXP regulated activities