Senior Quality Assurance Specialist

1 week ago

Philadelphia, United States Ivory Systems Full time

JOB SUMMARY

The Manager (Consultant), R&D Quality supports Research and Development by supporting the quality needs of the R&D Department with focus on pre-commercial GMP products and projects, working directly with clients and Project Managers to ensure positive customer interactions. The Manager, R&D Quality will also work with members of the Quality Operations department to monitor and approve R&D and PRD batch activities.


RESPONSIBILITIES AND LEARNING OPPORTUNITIES

  • Ensures Quality Systems compliance (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) and drives improvements specifically for R&D
  • Partners with Project Management to ensure a Quality voice and a high level of client support for ongoing R&D projects; including but not limited to participation in project meetings, and follow-up documentation
  • Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness
  • Support the R&D department in the evaluation of department SOP’s to drive efficiency and quality by design
  • Oversees the review and approval of development batch records for non-commercial GMP batches (clinical batches, tech transfer batches, for example)
  • Reviews and approves Design of Experiment and Critical Process Parameter Reports
  • Reviews and approves all quality related documentation produced by R&D, including sampling protocols, stability protocols, test method qualification and validation reports.
  • Reviews and approves investigations generated by R&D
  • Is a backup resource to the QA team that focuses on commercial product as needed by the Quality Director.
  • Participates in internal audits of the R&D department
  • Participates in developmental customer internal and external planning sessions
  • Interact with Customer’s Quality associates to fulfill client needs
  • Participate in Customer/Regulatory audits as needed
  • Reviews and approves investigations, assisting with determining root cause and recommends & implements corrective, preventive actions
  • Collaborate with all departments within the company as required
  • Ensure facility adherence to cGMP’s and SOP’s with special focus on R&D
  • Other duties as assigned


REQUIRED SKILLS AND QUALIFICATIONS

  • BS/BA degree in a Scientific discipline from a four-year accredited university or college.
  • 5+ years’ of related experience preferred.
  • Advanced knowledge GMPs specifically clinical GMP’s
  • Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
  • Strong communication skills, both written and verbal.
  • Operational knowledge of European GMPs.
  • Able to prioritize duties and manage multiple activities from start to finish with minimal supervision.
  • Exceptional attention to detail and excellent organizational skills.

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