Senior Quality Assurance Specialist - Cellares
View Company Profile- Job Title
- Senior Quality Assurance Specialist
- Job Location
- South San Francisco, CA
- Job Description
- We are seeking a talented and passionate Senior Quality Assurance Specialist to play a vital role in ensuring the quality and compliance of our product. This individual is detail-oriented and proactive. In this position, this hire will collaborate with various departments, including manufacturing, R&D, and engineering to review documentation, conduct/host audits, investigate deviations and lead projects.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
- Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client’s project until project closure
- Supports Clinical QA activities, including initial process development and non-clinical batch production
- Monitor day-to-day Quality Assurance activities in accordance with approved SOPs/Policies for cGxP integrated contract manufacturing facility
- Ability to troubleshoot, identify process pathways, and develop improvement strategies for site teams on projects/issues
- Understand advanced topics pertaining to cGMP
- Participate in regulatory inspections or customer audits as required
- Understand and articulate company business strategy, maintaining a broad view of the business and recognizing changes and trends
- Review executed batch records and logbooks efficiently to ensure compliance with cGMP per written procedures
- Compile lot genealogy and lot disposition packages, driving lot disposition activities to ensure timely product release
- Provide oversight to product status, including preparation of documents for shipping activities
- Oversee the quality tag-out system
- Actively participate in and approve deviation investigations, utilizing Root Cause Analysis tools for effective and timely closure
- Ensure correct implementation of CAPA based on deviations raised and ensure timely closure of CAPA
- Timely escalation of quality events on the floor based on knowledge of defined SOPs and policies
- Support changeover activities and QA on call
- Provide training to new members and manufacturing teams
- Provide quality oversight for operations document changes (e.g., MBRs, SOPs, forms, logbooks, etc.)
- Provide quality change request oversight for process and operation changes
- Detect non-compliance with cGMP and GDP requirements and provide guidance on GDP corrections
- Revise, review, and approve SOPs, protocols, reports, and records
- Perform any other tasks as assigned
Requirements- Bachelor’s degree in a related field (e.g., Life Sciences, Engineering, Quality Assurance, etc.)
- 5-8 years of experience in quality management or quality assurance, preferably in a regulated industry (e.g., medical devices, pharmaceuticals, cell & gene therapy, etc.)
- Strong knowledge with Regulatory requirements and local Codes & Standards (e.g., FDA, EMEA, and ICHQ7)
- Knowledge and experience of the practical and theoretical requirement of quality management system in GMP facility
- Team player who can operate independently, with strong focus on safety, quality and timelines
- Excellent communication, organizational, and analytical skills in a fast-paced, dynamic environment
- Strong attention to detail and commitment to ensuring high standards of quality and compliance
- 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