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QA Specialist - II*

Leadstack Inc

Oceanside, CA

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JOB DETAILS
SALARY
$45–$45 Per Hour
SKILLS
Analysis Skills, Biology, Campaigns, Change Control, Communication Skills, Document Control, Fortune 500 Customers, GMP (Good Manufacturing Practices), Interpersonal Skills, Laboratory Analysis, Laboratory Information Management System (LIMS), Maintain Compliance, Manufacturing, Microbiology, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Negotiation Skills, Operational Support, Operations Management, Operations Processes, Presentation/Verbal Skills, Quality Assurance, Quality Control, Quality Management, Regulations, Regulatory Compliance, Regulatory Requirements, Risk Analysis, Secondary School, Small Company, Stability Analysis, Team Player, Testing, Time Management, Writing Skills
LOCATION
Oceanside, CA
POSTED
8 days ago
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.

Job Title : QA Specialist – II
Location: Oceanside, CA
Duration: 12 Months
PR: $35/hr - $45/hr on W2
 
Job Description:
  • We are seeking a highly motivated individual to join us as a Quality Assurance Specialist II.
  • In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
  • You will be located at our Oceanside, CA site and report into the Sr. Manager of Quality Assurance Operations.
  • The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations
 
Key Responsibilities:
  • Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)
  • Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, nd Stability)
  • Approve shipments and provide oversight during packaging of product
  • Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
  • Ensure timely assessment and closure of Laboratory Investigations
  • Ensure timely assessment and closure of batch and material hold events
  • Communicate lot disposition pending issues to Management
  • Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areas
  • Perform walk-throughs and process observations
  • Perform Document Control administrative activities including archival and updating of site training records
  • Support Regulatory Body Inspections of the facility
  • Ensure products are manufactured in compliance with regulatory and GMP guidelines.
  • Escalate issues that may adversely impact timely release of product
  • Identify compliance risks and escalate the issues to appropriate levels of management for resolution
  • Generate and update procedures and forms as needed
  • Perform additional duties as needed
 
Basic Qualifications:
  • Master's Degree and OR
  • Bachelor's Degree and 2+ years' experience in the biological sciences or related field OR
  • AA Degree and 4+ years' experience in the biological sciences or related field OR
  • High School Degree and 5+ years' experience in the biological sciences or related field
 
Preferred Qualifications:
  • Quality Control background in Analytical, Virological, and Microbiological testing
  • Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
  • Ability to effectively negotiate and build collaboration amongst individuals
  • Proficient in MS Word, Excel, Power Point and other applications. Experience with Veeva, Smartsheet and LIMS is highly desirable
  • Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
  • Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
 
If you have any questions, feel free to call me on (415) 322-5419 or send an email on

akarsh.yathiraj@leadstackinc.com


 
Thanks and Regards
Akarsh Yathiraj
Senior Recruiter
 
C.(415) 322-5419
D.(415) 322-5419
A.611 Gateway Blvd, Ste 120
South San Francisco, CA 94080
W.www.leadstackinc.com

About the Company

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Leadstack Inc