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Sr Quality Assurance Specialist; Document Control
Spark Therapeutics, Inc
 
Job Location: Philadelphia, PA
The Sr Quality Assurance Specialist, Document Control and QA Systems manages and tracks all GMP documentation. This position will serve as the administrator for all QA computerized system/s. S/he will be the point contact person in the Quality Assurance department for any system related issues.

The Sr Quality Assurance Specialist, Document Control and QA Systems will be responsible for the implementation and on-going oversight of the documentation system (ensur) as well as other future electronic system initiatives for Quality Systems (e.g. deviations, Corrective and Preventive Actions (CAPA), change control, product complaints). S/he will serve as system administrator for these systems.

The Sr Quality Assurance Specialist, Document Control and QA Systems will be responsible for managing and tracking all GMP documentation as per Sparks document lifecycle procedures and archives all records in accordance with the records retention procedures.

This role will report into the QA Operations Lead and will also be expected to advise and provide input into the overall systems strategy. S/he will also lead and/or participate in projects and initiatives related to Data Integrity and QA verification of Audit Trails related to QC analytical instruments.

Specific responsibilities include:
  • Manage and maintain controlled documents in the Electronic Document Management System.
  • Independently review SOP and Form content and exercise judgement to provide suggestions to author to ensur alignment with Spark controlled document procedures and best practices
  • Track controlled documents to ensure reviews and approval are completed within the EDMS.
  • Coordinate the review, finalization and archival of Spark policies, procedures and other controlled documents
  • Edit and proofread controlled documents for consistency of document format and adherence to Quality Systems processes and procedures
  • Implement and utilize advanced Word processing and automation features of MS Office software
  • Lead the implementation of document control process improvements
  • Implementation and oversight of GMP documentation system ensur
  • Oversight of qualification and maintenance of current database tools used for trending QA information such as deviations, change controls and CAPAs
  • Serving as administrator for QA stand-alone systems
  • QA representative in supporting and/or participating in QC Data integrity initiatives
  • Provide assistance in the data management processEnsuring compliance of QA computerized systems
RESPONSIBILITIES:
15%
  • Select and implement and administer QA electronic systems
  • Review and approve validation related documentation

15%
  • Provides input and guidance, and may advise the Lead in the overall systems strategy

10%
  • Evaluate, implement and execute future electronic system
20%
  • Review and approve functional, operation and maintenance procedures related to QA systems and other dept systems as needed
  • Troubleshoot QA computerized systems

40%
  • Manage and maintain controlled documents in EDMS
  • Track controlled documents to ensure reviews and approval are completed within the EDMS.
  • Coordinate the review, finalization and archival of Spark policies, procedures and other controlled documents
  • Oversee use / maintenance of all QA systems
  • Ensure QA computerized system compliance
  • Working with QA Training personnel, develops and delivers training for all applicable systems

QUALIFICATIONS:
  • Ability to multi-task and work in a regulated environment
  • Ability to set and meet agreed upon timelines
  • Excellent communication skills, both oral and written
  • Ability to develop solutions to a variety of problems of moderate scope and complexity exercising judgment within defined procedures and practices to determine appropriate action
  • Ability to build productive working relationships internally and externally
  • Ability to work with limited supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy

REQUIREMENTS:
  • Bachelors or Masters degree in biological or chemical sciences
  • Generally, has a minimum of 5-7+ years of related work experience in the Pharmaceutical/Biotech industry
  • Experience with biopharmaceutical products, biologics or vaccines preferred
  • Must have strong GMP working experience
  • Must have solid working experience and solid knowledge of GMP Compliant electronic systems for managing document control, deviations, CAPAs and change control (e.g. Compliance Wire, ensur, Trackwise, Documentum, etc.)
  • Experience in reviewing and approving validation protocols and reports related to the systems

WHO WE ARE:

Transforming Patients Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.


















SPRKQualityAssurance




How To Apply:
You will be directed to another website for application instructions.
 
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