- Title: Quality Assurance Specialist
- Code: RCI-43546-1
- Location: Warren, NJ 07059
- Posted Date: 12/03/2021
- Duration: 12 Months
- Name:Sumit Rawat
- Email: email@example.com
- Phone: 908-704-8843 ✖ 232
Candidate is required to report onsite
MUST HAVE's: Functional responsibilities include On-Site coverage/participation in 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, Packout oversight and performing market release
- Senior Specialist, QA Operations is responsible for quality oversight of Cell Therapy Development Operations activities in accordance with client policies, standards, procedures, and Global cGMP requirements.
- Functional responsibilities include On-Site coverage/participation in 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, Packout oversight and performing market release, ensuring accurate and timely review and maintenance of clinical manufacturing GMP/batch related documentation and procedures.
- This position reports to the Senior Manager of Quality Assurance Operations.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Must have advanced 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 or no supervision.
- Work is self-directed yet collaborative with CTDO 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 Warren Manufacturing Operations, Supply Chain Operations, Warehouse, QA and QC Laboratory processes in the execution of Clinical Manufacturing of Cell Therapy Products
- Participate in Shop Floor and QC Laboratory Walkthrough programs.
- Printing, Issuance, Chain of Identify (COI) verification, and Reconciliation of finished drug product labels used by Manufacturing and Supply Chain Operations.
- Apply knowledge of quality processes, including batch record review, material disposition, triaging of deviations, investigations, CAPA, risk management, change control, and product complaints.
- Revise department SOPs, as well as, Review and QA Approval of CTDO SOPs
- Perform Real time review /approval of executed batch records and Chain Of Identity verification.
- Responsible for ERP Material Status Changes of production/drug product
- 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):
- B.S. scientific discipline or relevant college / university degree preferred.
- Minimum 5 years cGMP work experience with minimum 2 years of Quality experience.
- 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.
WORKING CONDITIONS: (US Only):
- Review Work is performed in a typical office environment, with standard office equipment available and used. QA Shop Floor Coverage/Lab Walkthrough Work requires standing and walking for up to 90% of the time on a given day. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
- This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
- This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.