QC And Technical Writing Lead

Spark Therapeutics Philadelphia , PA 19107

Posted 3 months ago

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.

Summary

The QC and Technical Writing Lead will report to the Immunology Leader within Translational Research. He or she will be responsible for:

  • Management of QC and Technical Writing group;

  • Establishing quality control processes for Translational Research such as writing technical documents in support of preclinical and clinical sample analysis, archiving, samples and reagent handling;

  • Reviewing and verifying accuracy and completeness of documents such as assay execution run records, reagent preparations, data and data tables, instrument logs, etc., according to regulatory requirements and good documentation practices; working with lab scientists to resolve documentation deficiencies;

Responsibilities

% of Time

Job Function and Description
30%

Ensure GLP compliance of technical documentation in Translational Research.
25%

Write technical documents including SOPs, assay development reports, validation protocols and bioanalytical reports.
10%

Perform document control quality reviews and edits of the documents authored by other group members.
10%

Coordinate with lab scientists to resolve document deficiencies
5%

Ensure quality of documents archiving
5%

Ensure quality of samples tracking and storage
5%

Ensure correct samples and reagents handling in the laboratory
10%

  • Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback. Hold everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.

  • Develop team members. Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employee's goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.

  • Foster Spark's Culture, Mission, Vision, and Values: Lead by example. Create an environment where team members thrive in our Culture by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that "how" they achieve performance objectives is just as important as "what" they accomplish.

Education and Experience Requirements

  • BS/BA or higher in relevant scientific discipline (health care, life science, biology, biochemistry, etc.)

  • Minimum 6 years of document quality control or quality assurance experience in a CRO or pharmaceutical environment

  • Some previous experience as a team leader is preferred

  • Experience in QC or QA review of lab generated records and data within the pharmaceutical/regulated industry;

  • Proven extensive technical writing experience with the ability to provide work examples of such experience;

  • Familiar with document change control programs e.g. Ensure

  • Familiar with LIMS

  • Excellent understanding of biological assays such as ligand-binding immunoassays, e.g. ELISA, cell-based assays e.g. ELISPOT, biochemical assays, qPCR assays, etc.; Hands-on experience running these assays preferred

  • Excellent understanding of GLP/GMP/GCP and regulatory guidance;

Key Skills, Abilities, and Competencies

  • Understanding of technologies/science in biopharma industry with a preference for experience in rare diseases and/or genetic medicine

  • High attention to details; ability to identify errors and incompleteness of lab generated documents

  • Extensive technical writing skills;

  • Proficient in Word, Excel, PowerPoint and GraphPad or other statistical tools

  • Strong interpersonal, analytical and organizational skills, flexible in problem solving

Complexity and Problem Solving

  • Considered expert in field within the organization

  • Develops solutions to complex problems which require the regular use of ingenuity and innovation

  • Ensures solutions are consistent with organization objectives

Nearest Major Market: Philadelphia

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QC And Technical Writing Lead

Spark Therapeutics