Senior Quality Assurance Specialist, Quality Operations - Cellares
View Company Profile- Job Title
- Senior Quality Assurance Specialist, Quality Operations
- Job Location
- Bridgewater, NJ
- Job Description
- We are seeking an innovative and highly motivated Senior Quality Assurance Specialist, Quality Operations, who will play a key role in establishing and optimizing global quality operations programs and contribute significantly to the growth of the Cellares team.This individual will be responsible for Quality oversight and support of cell therapy manufacturing operations, in full compliance with established cGMP requirements. Functions and activities include Disposition activities, including incoming materials and final drug product, QA shop floor support of manufacturing operations, Quality Assurance review and approval functions, and QC laboratory oversight, among others. This individual will develop, implement and execute QA Operations processes.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
- Manage the daily quality activities for the quality operations team to ensure facility, process, and materials are in compliance with cGMP requirements
- Partner with other functional team members to ensure harmonization and alignment with Quality Policies, Guidelines, Programs and Systems
- Performs tasks related to all aspects of incoming material and final product disposition for the site
- Responsible for batch record review activities for the site and coordinating Drug Product Release with clients
- Participates in quality shop floor program to ensure compliance of the manufacturing operations
- Responsible for providing quality oversight of the QC laboratory
- Write, review and approve Standard Operating Procedures (SOPs) and associated Work Instructions (WI) and Forms (FRMs), or other documentation, as needed
- Evaluate the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement to organizational agility
- Act as QA lead for the design, implementation, and continuous improvement of QA digital systems (SAP, LIMS, etc.)
- Drive startup activities related to system validations, master data setup and user training
- Coordinate quality systems related activities among impacted individuals, departments, sites and companies as needed to proactively support business processes
- Establish effective partnerships with business units, sites, and individuals to ensure business processes are effectively linked
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements
- Cross train on compliance related activities
- Other duties will be assigned, as necessary
Requirements- Bachelor’s degree in a scientific or engineering discipline
- 5-8 years in a GMP environment with at least 3 years of Quality in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC
- Excellent knowledge of the regulations for biologics, cell and gene therapy products
- Strong knowledge of current Good Manufacturing Practices (cGMP)
- Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches
- This role requires a strategic mindset, hands-on problem solving skills, and ability to adapt to evolving business needs.
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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