Johnson Service Group, Inc., is actively seeking a Quality Assurance Specialist III, Labeling Commercial division to work with our client outside of the Los Angeles, CA area.
In this role, you will work in partnership with Supply Chain, Regulatory Affairs, and Manufacturing Site Quality teams to ensure compliance to Commercial product labeling processes which includes implementation of process improvements.
Responsibilities: Perform the Quality review and approval for commercial final product labeling artwork (labels, package inserts (PI), patient information leaflets (PIL), master packaging configurations (MPC), and artwork proofs in support of regulatory filings, launch and variation management.
Provide labeling advice in alignment with QA policies and procedures and Quality oversight to ensure labeling processes are cGMP compliant.
Quality Assurance Approver of labeling Change Controls and Change Control tasks ensuring proper documentation of completion and timely implementation.
Quality Assurance Approver on labeling content Deviations, Corrective and Preventive Actions (CAPA), Effectiveness Verifications, ensuring proper investigation, remediation, problem resolution, and timely closure.
Participates in writing or suggesting changes to controlled documents (e.G., SOPs, forms) as needed to ensure defined quality objectives are met.
Assess, define and implement ideas to promote continuous improvement of commercial labeling processes and systems in alignment with industry best practices.
Support audits (internal, external) in order to verify that labeling regulatory and quality requirements have been met.
Ability to identify and escalate compliance gaps for current state and future state process changes.
Participate and contribute to regular meetings held by the Quality organization and represent Quality at cross-functional meetings.
Qualifications: Bachelor’s degree in a scientific field and 5+ years’ experience in a GMP environment related field Quality or Regulatory experience in pharmaceutical artwork content review Quality or Regulatory experience in a pharmaceutical, biotech or cell and gene therapy operations Knowledge of the global cGMP regulations and regulatory requirements for commercial packaging and labeling of drugs, biological and cell and gene therapy products globally (U.S., EU and ROW) Attention to detail with the ability to proofread labeling content for transcription errors An understanding of pharmaceutical labeling systems and processes Strong presentation, analytical, problem-solving, time management and organizational skills Excellent verbal, written and presentation skills and the ability to collaborate with multifunctional, global teams Ability to build and maintain positive relationships at all levels, influence, and lead people.
Comfortable in a fast-paced environment with minimal direction and able to manage multiple tasks, and meet deadlines associated to changing priorities Demonstrates proficiency in Microsoft Office applications Please send resumes to Kathleen Rouse at krouse@jsginc.com and contact me directly at 770-635-1347 #D200