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Sr QA Specialist

Date: Aug 15, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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 Quality Assurance Specialist will:

  • Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark
  • Review and evaluate QC testing records and any associated OOS investigations
  • Review/Approve/Write/Revise Standard Operating Procedures and Technical Documents/Reports
  • Provides general guidance/instructions to less senior members of staff
  • Work closely with QA, QC and Manufacturing Functional Management to identify strategies, tactics and objectives for product quality and GMP compliance
  • Oversee GMP manufacturing operations
Responsibilities

Conduct record review of executed production records for reagents, bulk drug substance, drug product and packaged lots.

Review deviations, as appropriate, based upon Spark Manufacturing team and/or Contract Manufacturing Organizations (CMO) and/or Contract Technical Laboratories (CTL) notification; confirm evidence of on-time document closure for product disposition

Assure all Deviation/Investigations, Change Controls, CAPAs, and/or other required documentation related to the lots are completed and closed prior to material/lot release

Author and revise master production records, standard operating procedures and other documents used in the manufacture of clinical and/or commercial products

Review, write, revise, approve SOP’s, technical documents and reports

Review vendor certificates for completeness / compliance against approved specifications

Assist in audits of CMOs and/or CTLs

Evaluate analytical results against approved specifications to determine compliance, release materials for use and/or provide an appropriate disposition for product

Prepare certificates of compliance (CoC) and/or certificates of analysis (CoA) for products for clinical and/or commercial materials

Evaluate lot test results against trending data to identify any irregular trends

Support preparation of regulatory submissions

Other assigned responsibilities as established by QA Operations Lead

Requirements
  • BA/BS in scientific discipline required and/or 5-10 years equivalent industry experience or MS with 3-7 years equivalent industry experience.
  • Pharmaceutical manufacturing environment with exposure to Quality and Manufacturing field is recommended for this position.
  • Broad knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations
Competencies
  • Broad knowledge of Quality Systems such as Change Control, Investigations and CAPA
  • Ability to communicate effectively with wide range of personnel
  • Solid technical writing skills related to investigation reports
  • Ability to organize cGMP system procedures based on regulatory / compliance regulations
  • Must have strong attention to detail
  • Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control and validation data
  • Ability to lead (as necessary) and participate on cross-functional teams in root cause analysis and solution identification
  • Proficiency with computer programs
  • Develop solutions to a variety of problems of moderate scope and complexity. Refers to policies and practices for guidance.
  • Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.  Exercises judgment within defined procedures and practices to determine appropriate action.  Builds productive working relationships internally and externally.
  • Works under minimum supervision. Work is reviewed for soundness of judgment and overall adequacy and accuracy.
  • Contributes to the completion of organizational projects and goals. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
  • Ability to establish facts, define problems, collect data and draw valid conclusions


Nearest Major Market: Philadelphia