52 Sr QA Specialist Jobs in El Segundo, CA
LanceSoft Inc is Hiring a Sr QA Specialist Near El Segundo, CA
NOTE: Position is Day Shift including weekends and requires onsite presence.
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
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 Summary
Full Time
Business Services
$127k-154k (estimate)
06/13/2024
07/11/2024
lancesoft.com
HERNDON, VA
500 - 1,000
2000
Private
DIVYA GANDHI
$200M - $500M
Business Services
Related Companies
About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
The job skills required for Sr QA Specialist include Written Communication, Collaboration, etc. Having related job skills and expertise will give you an advantage when applying to be a Sr QA Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Sr QA Specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Sr QA Specialist positions, which can be used as a reference in future career path planning. As a Sr QA Specialist, it can be promoted into senior positions as a Quality Assurance Specialist V that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Sr QA Specialist. You can explore the career advancement for a Sr QA Specialist below and select your interested title to get hiring information.
Similar Jobs
Popular Articles
