Field Specialist QA Operations

Summit, New Jersey

Job Title: Field Specialist QA Operations
Location: Summit, NJ
Duration: 6 Months

Functional Responsibilities:

  • QA Shop Floor and QC Laboratory Walkthrough activities
  • Label Printing and Issuance of finished drug product and shipping labels
  • Event Triage including Deviation and CAPA QA Review and Approval
  • Provides QA oversight on deviations, CAPAs and change controls
  • Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP/batch-related documentation and procedures
  • Product disposition and raw material release

Required Competencies: Knowledge, Skills, And Abilities:

  • Must have knowledge and Quality experience with cGMP manufacturing US and global requirements
  • Must possess an independent mindset and have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management principles
  • Must be skilled in planning and organizing, decision-making, and building relationships
  • Requires moderate direction to complete more complex tasks; completes routine tasks with little supervision
  • Work is self-directed yet collaborative with CTD counterparts
  • Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues
  • Follows established procedures and performs work as assigned and develops procedures as needed
  • Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution. Proposes solutions for complex issues and works with management to resolve
  • Able to prepare written communications and communicate problems to cross-functional counterparts and management with clarity and accuracy

Duties And Responsibilities:

  • Provide functional QA oversight of S6A Manufacturing Operations, Warehouse, QA and QC Laboratory processes in the execution of clinical manufacturing of gene delivery materials
  • Participate in Shop Floor and Quality Check Walkthrough programs
  • Issuance of batch records
  • Apply knowledge of quality processes, including batch record review, material disposition, triaging and review and approval of deviations, investigations, CAPA, risk management, change control, and product complaints
  • Revise department SOPs, as well as review and QA approval of CTD SOPs
  • Perform review /approval of executed batch records
  • Maintains current knowledge of industry standards as it applies to cGMPs and global regulatory guidelines and requirements
  • Supports Risk Assessments/projects as required by senior management

Education And Experience (As Applicable):

  • Bachelor’s degree required
  • B.S. scientific discipline or relevant college / university degree required
  • Minimum 2 years cGMP work experience. Quality experience, preferred
  • Equivalent combination of education and experience acceptable
  • Strong knowledge of cGMP Quality and Compliance principles required
  • Clinical and Phase appropriate experience preferred
  • Strong cross-functional collaboration experience required

Summary Of Preferred Experience For This Position:

  • 1 years of Shop floor
  • 1 years of Investigation, root cause analysis, CAPA and change control knowledge
  • 1 years Quality background
  • 1 years, batch record review

Additional Job Requirements: 

  • Position Handles Hazardous Materials

About SSi People:
With over 25 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering an exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.

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