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Quality Control Analyst III
Ref No.: 18-02342
Location: Malvern, Pennsylvania
Position Type:Contract
Start Date / End Date: 05/01/2018 to 12/21/2018
Job Title: QA Specialist III
Location: Malvern, PA
Duration: 7 Months


Job Missions:
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.

Key Contributions & Activities:
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 Required:
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.

Latitude of action
R&D Quality Support for Clinical Supplies
Critical
Clinical Supplies GXP regulated activities

Education:
Bachelor's degree or equivalent in Science or Engineering with 3+ years of cGMP experience or equivalent related experience

Professional Experience:
6+ years of cGMP experience or equivalent related experience


Core Competencies:
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.