Senior Quality Specialist- cGMP Compliance (Onsite, Warren, NJ)
We are looking for a Senior Quality Specialist for a Global pharmaceutical Company. The focus of this role is to support the Quality Engineering group from a Subject Matter Expert (SME) standpoint in accordance with the client’s policies, standards, procedures, and Global cGMP and to facilitate the Change Control Review Board (CCRB) and record tracking meetings as applicable, driving proactive and corrective improvements within Operations, providing support at all regulatory inspections and corporate audits, tracking internal/external audit commitments and driving on-time closure, evaluation of new requirements and emerging regulations, providing user support for the different Quality Systems as a site lead which includes integration activities and generation and review of Site Quality Metrics.
This is a 40-hour per-week, 12-month contract (extensions possible), 100% onsite role in Warren, NJ (The candidate must be able to work onsite 5 days a week).
This is a W2 role as a Stage 4 Solutions employee. Health benefits and 401K are offered.
Responsibilities
- Ensure control of systems, processes and products through facilitation of CCRB
- Represent site and provide impact assessment for global changes at Global CCRB
- Monitor and track external audit/inspection commitments to ensure timely closure.
- Track site change controls and ensure appropriate requirements are identified and completed for implementation
- Provide weekly change control due date updates to the Tier board metrices.
- Must be skilled in planning and organizing, decision-making, and building relationships.
- Familiar with Veeva Vault QMS system.
- Able to effectively multi-task.
Requirements
- 5+ years of experience in the pharmaceutical or related industry.
- Experience with cGMP manufacturing, Quality, and compliance.
- Thorough knowledge of and competence in quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.
- Directs quality initiatives that accomplish continuous improvement and enhance site manufacturing efficiencies, while providing a safe and compliant process.
- Must be able to effectively prepare communications with interpretation of data analysis and potential problems to management and the group with clarity and a high level of accuracy.
- B.S. degree
Please submit your resume to our network at https://www.stage4solutions.com/careers/ (please apply to the Senior Quality Specialist- cGMP Compliance (Onsite, Warren, NJ) role).
Please feel free to forward this project opening to others who may be interested.
Stage 4 Solutions is an equal-opportunity employer. We celebrate diversity and are committed to providing employees with an inclusive environment that is free of discrimination and harassment. All employment decisions are based on the job requirements and candidates’ qualifications, without regard to race, color, religion/belief, national origin, gender identity, age, disability, marital status, genetic information, or other applicable legally protected characteristics.
Compensation: $60/hr to $64/hr