Quality Assurance Specialist II

4 weeks ago

Hopewell, United States IT MINDS L.L.C. Full time
Job Title: QA Manufacturing Specialist II

About the Role:

We are seeking a highly skilled QA Manufacturing Specialist II to join our team at IT MINDS L.L.C. in Hopewell, NJ. As a key member of our Quality Assurance team, you will play a critical role in ensuring the successful day-to-day management of reviewing and approving GMP paperwork, including logbooks, analytical raw data, Environmental Monitoring reports, and other ancillary documentation that supports GMP Manufacturing.

Key Responsibilities:

  • Supports/participates in regulatory and customer inspections/audits as required.
  • Maintaining and improving QA operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers.
  • Implementing and monitoring all Quality Assurance activities in laboratories and facility/utility space to ensure compliance with FDA/EU regulations, covering cGMP for commercial medicinal products and clinical material for human use.
  • Ensuring the QA Compliance of departmental SOPs (writing & revising), ensuring regulatory compliance in conjunction with being 'fit for purpose' operationally and commercially.
  • Knowledgeable in cGMPs: 21 CFR Parts 11, 210, 211, and 600.
  • Demonstrated expertise with ERP systems such as Maximo, Veeva, LIMS, MODA, and SAP.
  • Ensuring all activities are performed in accordance with GMPs, SOPs and Health and Safety policies.
  • Awareness of USP/EP, ICH Guidelines, QC methodology updates to ensure compliance with current testing and specifications.
  • Ensuring appropriate escalation and follow up for non-conformities within Laboratories and Utility areas, and issuing deviations when appropriate.
  • Ensuring that the Quality department meets or improves key performance indicators (KPIs).

Requirements:

  • Scientific degree (ideally biotechnology, biology, pharmacy, pharmaceutical sciences, chemistry or related scientific field) or equivalent work experience.
  • Required 3+ years (B.S. degree) or 1 years (M.S. degree) of GMP Pharmaceutical experience working in a quality assurance or quality control role in an FDA-regulated company.
  • Working knowledge of cGMPs: 21CFR parts 11, 210 & 211, knowledge of 21CFR600 Biologics desirable.
  • Good personal leadership skills and experience. Good collaboration ability.
  • Credible and confident communicator (written and verbal).
  • Customer focused, Strong analytical and problem-solving ability.
  • Good project management skills.
  • Hands-on approach, with a 'can do' attitude.
  • Ability to prioritize, demonstrating good time management skills.
  • Attention to detail, with the ability to work accurately & efficiently in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative. Innovative thinker.
  • Committed to learning and development.
  • Highly Desirable: Good IT skills e.g., Microsoft Office (Word, Excel, PowerPoint, Project and Outlook)

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