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Company : Eclaro
Job Number: (phone number removed)
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for a QA 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!
Specialist, QA Operations, is responsible for quality oversight of Client activities in accordance with Client policies, standards, procedures, and Global cGMP requirements.
This position reports to the Senior Manager of Quality Assurance Operations.
Position handles hazardous materials.
Label Printing and Issuance of finished drug product and shipping labels.
Event Triage Packout oversight and performance of release-to-market.
Ensuring accurate and timely review, as well as maintaining, clinical manufacturing GMP / batch related documentation and procedures.
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 Quality Check 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 Client 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.
BS / MS in a related scientific discipline.
Minimum 4 years of experience within QA functions in the Pharmaceutical Industry.
Thorough knowledge of cGMP in the Pharmaceutical Industry.
Good understanding of the drug development process.
Knowledge and application experience with batch record review, product disposition / release, change control, SOP review, and GMP inspection.
Good computer skills and working knowledge of common business software.
Excellent organizational skills.
Excellent problem-solving, verbal, and written communication skills.
Must have strong interpersonal and communication skills, be a team player.
Must be an individual with proven initiative and demonstrated accountability.
Professional integrity and maturity.
Equivalent combination of education and experience acceptable.
Strong cross-functional collaboration experience.
Clinical and Phase appropriate experience.
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:
(phone number removed)
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.