Quality Assurance Specialist II
4 weeks ago
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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