Job Number: 21-02261
Job Number: 21-02261
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for QA Specialist for our client in New Brunswick, 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!
- Performs specific quality related functions such as GMP/procedural training, materials/products release, quality incident investigations, change control review and approval, to ensure compliance with GMP regulations and Client standards.
- Reviews, in a timely manner, all batch documentation associated with investigational medicinal products (IMPs) externally manufactured for Client and releases those found in compliance into SAP and QMS as applicable.
- Conducts, plans, schedules the review and approval of GMP records, data, and other release documentation as needed, intended for the manufacture of investigational medicinal products.
- Reviews and approves documents related to Quality Systems such as CMO master batch records, manufacturing and laboratory investigation reports, and other documents as needed.
- Provides instruction and guidance on quality issues and serves as a resource for the site.
- Brings to the attention of the Quality Operations Management, any information relating to the impact of legislation on the functions of the department, system deviations, etc.
- Performs the monitoring program as required.
- Provides reports to Management related to timely CAPA implementation or other issues, as requested.
- Adherence to Client core behaviors.
- Keeps CMC QA aware of potential quality issues with potential impact on study supplies.
- Coordinate and author Quality Agreements (Vendor and Collaboration).
- Supports site operations during regulatory agency and third party inspections.
- BS in a related scientific discipline.
- 2+ years of experience within QA functions in pharmaceutical industry.
- Decision-making regarding disposition for distribution of clinical trial materials and materials for production, based on documentation review.
- Decision-making where commitment is required on release dates for product and/or material.
- Works to resolve problem that may arise when a product or material needs to be released in a short time frame and documents received are incomplete and/or contain errors.
- Demonstrates initiative to clarify unclear situation in the presence of documentation irregularities.
- Prioritizes when handling multiple work assignments and deadlines. Provides clear direction and priorities.
- Works with a minimum of supervision.
- In-depth knowledge of GMP regulations and good understanding of drug development process.
- Strong interpersonal and organizational skills.
- Effective written and verbal communication.
- Computer literacy: Microsoft Office and SAP environment, Veeva, Trackwise, PDLIMs, and other systems as required (e.g. DeltaV, Pilotclean).
- QA Specialist acts as authorized delegate in the absence of the Quality Operations Manager
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.