Quality Records Specialist at Eclaro
Summit, NJ
About the Job
Quality Records Specialist
Job Number: 24-02742
Job Number: 24-02742
Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Quality Records Specialist for our client in Summit, 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!
Position Overview:
- The Global Supplier Quality, External QC-Vector will process external deviation and change records from the Contract Test Laboratories (CTL).
- Other duties may include: Coordinate testing of samples for lot release, PPQ, PSQ and will compile vendor documentation to generate a Client CoA / CoT.
- This role will partner cross functionally with Global Product Quality, External Manufacturing Supply Chain, and Global Supplier Quality to release vector in a timely manner for commercial, clinical and early development programs.
Responsibilities:
- Initiation, facilitation, and tracking of quality records.
- Provide regular communication and metrics for status of quality records.
- Effectively communicate issues, risks and proposed solutions within the organization.
- Provide communication, support, and guidance to CTLs within the QA vector and upstream material team.
- Other duties may include:
- Create and revise SOP.
- Create and revise Certificates of Analysis (CoA) and Certificates of Testing (CoT).
- Enter data and retrieve information from SharePoint and Smartsheet testing trackers.
Required Skills:
- Experience with deviation and change control management, preferably with Infinity systems.
- Strong organizational skills, including ability to follow assignments through to completion.
- Ability to work in a fast paced environment, meet deadlines, and prioritize work from multiple projects.
- Excellent verbal and written communication skills, and ability to work within inter-disciplinary and cross-functional teams.
- Detail oriented with demonstrated application in problem solving.
- With moderate oversight from manager, think strategically and understand global impact of decisions.
- Ability to participate in conference calls.
Preferred Qualifications:
- Advanced project management skills such as Process Excellence / Six Sigma Methods and approaches including process mapping, root cause analysis and problem definition.
- Experience within the Cellular Therapeutics and / or gene-based products.
- Experience with biologics will be considered.
- Experience with Clinical and / or Commercial products manufacture, supply and post-approval change management.
- Knowledge of applicable FDA / EMA regulations in the biotechnology industry.
- Experience managing external suppliers and other supply chain issues.
- Experience with Quality Systems (change control, deviation and investigation).
- Bachelor’s in relevant Scientific Discipline, or 3 years' experience in Bio-Therapeutics / Bio-Manufacturing QC / QA.
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:
Paul Quibuyen
Christian.Quibuyen@eclaro.com
646-695-2942
Paul Quibuyen | 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.