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QA Manufacturing Specialist II
2 months ago
QA Manufacturing Specialist II (Hopewell NJ)
Background: Our client is looking for QA Manufacturing support to assist in the ramp up of their new R&D facility in New Jersey.
Project: Supports QA manufacturing activities in the Warehouse, DS/DP production areas, QC Laboratories as well as Facility/Utility areas that support GMP manufacturing. Candidate will ensure 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. Works to support QA objectives whilst adhering to regulatory compliance and achieving business success. Creates and/or reviews SOPs needed to support the business. Works to support both internal GMP audits and Health Authority audits.
Required Skills:
Essential Functions of the job:
- Supports/participates in regulatory and customer inspections/audits as required.
- Maintaining and improving QA operational performance, to meet the requirements of regulatory authorities, BeiGene Global Standards, 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).
- Undertaking any other duties for any department within the business, which may be requested by Management, for which training and/or an explanation has been provided and understood Core Competencies, Knowledge, and Skill 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)
