QA Specialist II
Collabera Inc.
Quality Assurance
El Segundo, CA, USA
Posted 6+ months ago
QA Specialist II
Contract: El Segundo, California, US
Salary: $50.00 Per Hour
Job Code: 350996
End Date: 2024-09-04
Days Left: 23 days, 6 hours left
To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!
Pay Range - $45 to $50/hr. (negotiable)
Job Description:
Job Roles & Responsibilities:
- We are seeking a Senior Specialist of Quality Operations responsible for Product Disposition.
- This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
- This position is located at our El Segundo, CA site and report into the Associate Director of Quality Operations.
Responsibilities:
- Perform Product Disposition and Lot Closure.
- Includes commercial and clinical products.
- Review batch-related documentation and ensure resolution of issues to release product
- Review batch-related shipment documentation to ensure product shipment remained in control
- Provide QA oversight and review of deviations tied to lots.
- Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
- Provide QA oversight and (limited) approval of CAPAs. Ensures that associated CAPAs are initiated and resolved.
- Provide QA oversight and approval of change records. Ensures that change records are initiated and resolved.
- Support and participate in investigations, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing
- Maintain metrics related to product disposition in support of the Management Review
- Generate and update procedures, forms and other documents
- As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions, etc.
- Generate and report data for management
- Maintain production (finite), disposition, and team schedules
- Represent Disposition or QA Ops at plant and multi-site scheduling meetings
- Provide QA representation on projects and at team meetings
- Provide QA representation at multi-site disposition meetings
- Support and participate in inspections and audits
Basic Qualifications:
- Master’s Degree and 5+ years of experience in GMP environment OR
- Bachelor’s Degree and 7+ years of experience in GMP environment OR
- High School Degree and 11+ years of experience in GMP environment
Preferred Qualifications:
- Bachelor’s degree in the biological sciences or related field and minimum of 7 years progressive experience in a pharmaceutical, biotech, or biologics operation, or equivalent education/work experience.
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to interpret and apply procedural and regulatory guidance in potentially ambiguous situations
- Ability to understand risk and provide phase-appropriate appropriate decisions
- Ability to effectively negotiate and build collaboration amongst individuals
- Good interpersonal skills
- Strong written communication skills
- Strong analytical skills
- Comfortable in a fast-paced small company environment and operate with minimal direction
- Ability to adjust workload based upon rapidly changing priorities
Job Requirement
- QA Specialist
- Quality Assurance
- Quality Operations
- CAPA
- Documents
- biological sciences
- GMP
- cGMP
- GDP
- Biotechnology
- Pharma
- Pharmaceuticals
Reach Out to a Recruiter
- Recruiter
- Phone
- Chitrank Rastogi
- chitrank.rastogi@collabera.com
- 4255231648