Quality - Quality Assurance Specialist Quality Assurance Specialist
Quality Assurance Specialist
Job Number: 21-14824
Job Number: 21-14824
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a Quality Assurance Specialist for our client in Warren, NJ.
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
- 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.
- 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.
- 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.
- 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.
If hired, you will enjoy the following Eclaro Benefits:
- 401k Retirement Savings Plan administered by Merrill Lynch
- Commuter Check Pretax Commuter Benefits
- Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
June Binuya | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.