Senior QC Specialist-Raw Materials and Incoming Inspection

Location
Philadelphia, Pennsylvania
Salary
Salary not provided
Posted
November 24 2021
Ref
796680900
Organization Type
Biotech

Primary Duties:

The Senior QC Specialist-Raw Materials and Incoming Inspection is a critical member of the Quality Control & Analytical Sciences team. She/he will be responsible for the day-to-day oversight and inspection of the incoming raw materials at Spark Therapeutics, Inc. to support Technical Operations (Quality Control, Facilities and Manufacturing) and Quality Assurance for both commercial and clinical programs.

QC Raw Materials and Incoming Inspection includes, but is not limited to, establishing inspection and testing requirements, inspects and releases incoming raw materials, and participates in vendor qualification activities.

Specific responsibilities include:

  • Establish inspection and testing requirements for incoming materials such as raw materials and components used in the laboratories and manufacturing.
  • Revise and maintain specifications, standards, and operating procedures to global regulatory standards.
  • Experience with vendor qualification, setting raw material specifications, managing timelines and vendors at external facilities.
  • Review incoming materials against specifications and submit samples to QC Labs (internal and external) for testing.
  • Manage and maintain raw material retains.
  • Collaborate with Materials Management to optimize orders to support manufacturing while streamlining the testing.
  • Serve as SME for new raw material risk assessments that will consider supplier information, general industry knowledge, and technical evaluations based on process and material knowledge with a focus on fitness of each material for its intended use in the process.
  • Generates metrics for routine visibility and trending.
  • Supports Spark QC in regulatory submissions and inspections.
  • Supports Spark Manufacturing by managing testing schedule to maintain material inventories, and communicate to Materials Management, QA, and Manufacturing if there are delays with third party laboratories or OOS results.
  • Lead and support continuous improvement projects within Spark QC.
  • Reviews documentation generated by the QC and Contract Testing Laboratories (CTL) for accuracy and GDP.
  • Generate and review SOP’s, Technical Documents, Technical Protocols and Reports for the Technical Operations team.
  • Lead non-conformance (OOT/OOS) investigations, CAPAs, risk assessments, and change controls associated with both in-house and outsourced testing.
  • Through routine surveillance of current guidelines and regulatory opinion, identify potential gaps and develop strategy to address any gaps appropriately to ensure compliance of the microbiology and compendial testing programs.
  • Support in-process/product inspection issues and deviations that occur at our CDMOs as needed.

Responsibilities:

% of Time

30%

  • Inspection of incoming raw materials and management of the testing activities both at Spark and at contract laboratories.
  • Establish quality requirements for new raw materials as needed.
30%

  • Assist the QC Microbiological Control and Compendial Testing Leader and generate policies and procedures related to raw material testing required by USP/EP/JP as applicable for commercial and clinical programs.
  • Lead non-conformance investigations, risk assessments, and other required QA documentation related to samples tested on-site and outsourced, as well as material generated by CDMOs.
20%

  • Generate reporting of metrics and quarterly trending.
  • Support QC Microbiological Control and Compendial Testing Leader during Management Review and operational meetings.
  • Support raw assessments as SME
10%

  • Support and review of regulatory submissions.
  • Support Spark during audits and regulatory submissions.
  • Routine surveillance of current guidelines and regulatory opinion.
10%

  • Support in-process/product inspection at CDMOs.

Education and Experience Requirements:

  • BS degree required, in the biological or chemical sciences preferred.
  • Minimum of 7 years of QC, raw material release or inspection experience in a regulated Bio/Pharmaceutical industry with biopharmaceutical products, biologics or vaccines required.
  • Demonstrated working knowledge and application of AQL sampling requirements
  • Demonstrated strong working knowledge of GMP manufacturing.
  • Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
  • Experience in leading and supporting investigations and making decisions around issues that arise in the facility, laboratory, and manufacturing related to the area of responsibility.

Key Skills, Abilities, and Competencies:

  • Hands on experience performing quality control testing.
  • Ability to multi-task and workin a regulated environment.
  • Ability to set and meet agreed upon timelines.
  • Excellent communication skills, both oral and written.
  • Ability to assist and develop solutions to a variety of problems of high complexity, exercising judgment within defined procedures and practices to determine appropriate action.
  • Ability to build productive working relationships internally and externally.
  • Ability to manage multiple contract laboratories.
  • Ability to work with limited supervision.
  • Ability to interpret regulatory guidance and assess against current industry best-practice to develop policies and procedures.

Complexity and Problem Solving:

This position requires experience and knowledge of regulatory guidance and industry best practice in quality control such to proactively identify potential product and assay issues and raise the concerns to management as well as assist with the establishment of policies and procedures.

It is also expected to identify potential regulatory concerns and assess risk from routine analysis of sample data, deviations and excursions, as well as audits and review of information from CDMOs and laboratory service providers. The employee supports investigations and assists the QC Microbiology Leader to make decisions around issues that arise in the facility, laboratory, and manufacturing related to the area of responsibility.

#LI-2326

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location. Accommodations may be made in accordance with applicable law.


Nearest Major Market: Philadelphia



Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

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