Senior Quality Systems Specialist - Cellares
View Company Profile- Job Title
- Senior Quality Systems Specialist
- Job Location
- Bridgewater, NJ
- Job Description
- We are seeking an innovative and highly motivated individual to join us as the Senior Quality Systems Specialist at our IDMO located in Bridgewater, NJ. You will be responsible for maintaining the Quality System within the requirements of FDA’s GMP regulations.The primary focus of this position will be to manage the day to day activities of the eQMS including document control, and training.This is a multidisciplinary role & this individual will further interface across many parts of the company to develop novel products used in the cell therapy and gene therapy world. This role will be a hands-on resource and will be required to be on-site.Candidates should enjoy working in a fast-paced, mission-driven environment, and be prepared to tackle a broad selection of challenges as the company grows.Responsibilities
- Responsible for administrative controls, system configurations, periodic system upgrades and continuous improvement efforts of the eQMS, as needed
- Maintain and improve quality system procedures and programs including training programs, document control
- Manage the periodic review program of the eQMS
- Coordinate employee training; including, employee onboarding to the QMS, daily training tasks within the eQMS, training plans, and training content, etc.
- Coordinate document control processes within the eQMS, including reviewing document formatting, periodic reviews of documents, training authors and approvers to use the system, etc.
- Maintain metadata integrity and submission of DCRs, assuring correctness / compliance with local and corporate procedures
- Drive global system / process improvements (supports administration of the Document Control system, process harmonization activities, system updates and upgrades, etc.)
- Coordinate Document Periodic Review schedule, notifications to the Global Process Owners, and monitor Periodic Review status
- Support internal and external audits and client inspections, as needed, including backroom support
- Develop quality system metrics for training program, document control, productivity and effectiveness to be presented during the Quality Management Review
- Establish and promote an environment that supports the Quality Policy, Data Integrity and Quality System
Requirements- Bachelor's degree or higher in a relevant scientific discipline - Biotechnology, Biology, Biochemistry, or Chemistry
- 5+ years experience in a GMP environment
- Strong technical knowledge of cGMP regulations and eQMS systems
- TrackWise Digital experience preferred
- Strong working knowledge of quality systems and regulatory requirements including 21 CFR Part 11/210/211
- Strong understanding of regulatory inspection and knowledge of their requirements
- Ability to build strong working relationships with cross-functional departments
- Excellent interpersonal, verbal, and written communication skills
- Comfortability in a fast-paced environment with minimal direction and able to adjust to a dynamic work environment
- Self-awareness, integrity, authenticity, and a growth/entrepreneurial mindset
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Cellares Company Size
Between 100 - 500 employees
Cellares Founded Year
2019
Cellares Total Amount Raised
$355,000,000
Cellares Funding Rounds
View funding detailsSeries C
$255,000,000 USD
Series B
$82,000,000 USD
Series A
$18,000,000 USD