Quality Control Laboratory Specialist

Ampcus Incorporated

Tarzana, CA

JOB DETAILS
SALARY
$25–$30 Per Hour
SKILLS
Analysis Skills, Analytical Development, Analytical Method Development, Analytical Method Validation, Assays, Automation, Automation Engineering, Bioengineering, Business Services, Calibration, Cell Analysis, Cell Biology, Change Control, Communication Skills, Consulting, Corrective and Preventative Action (CAPA) Systems, Cross-Functional, Current Good Manufacturing Practice (cGMP), Data Quality, Digital Polymerase Chain Reaction (Digital PCR), Documentation Review, Equipment Maintenance/Repair, High Throughput, Identify Issues, Immunology, Laboratory, Laboratory Automation, Laboratory Information Management System (LIMS), Laboratory Management, Leadership, Problem Solving Skills, Quality Control, Regulations, Specimens/Samples, Standard Operating Procedures (SOP), Team Lead/Manager, Technical Support, Technical Writing, Validation Plan, Validation Testing, Writing Skills
LOCATION
Tarzana, CA
POSTED
6 days ago

Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.

Job Title:Quality Control Laboratory Specialist

Location(s):Tarzana, California

Job Summary:

Client is seeking an energetic and experienced individual with method automation background to join our Quality Control (QC) team. The Automation Engineer / Analyst, QC Analytical will lead the effort of validating automated workflows for dPCR and Flow cytometry methods. This role will work within QC Analytical team and collaborate with IT, Analytical Sciences, and facility teams to validate the CAR percentage and Vector Copy Number methods for our late phase cell therapy product. The successful candidate will lead the team to transition from our manual assays into compliant, high-throughput automated processes within a regulated cGMP environment.

Key Responsibilities:

  • Perform automated dPCR, flow cytometry, and other supporting procedures to validate the methods and enable the release testing and stability monitoring of cell therapy products and in-process samples.
  • Support technical transfer from Analytical Development, receive analytical method training, pre-qualification tests, and validation executions.
  • Act as a subject matter expert in technical discussion, document review, and investigations.
  • Prepare departmental SOPs, technical documents, undertake investigations, and draft troubleshooting plans.
  • Support quality events (change control, deviations, and CAPA), QC Operations, including LIMS implementation, equipment qualification, maintenance and calibration, and Sample Management.
  • Perform other duties as requested by supervisor to support the implementation of automated methods.
  • Author and/or review analytical test results, technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method validation protocols and reports, standard operating procedures (SOP).

Required Qualifications:

  • Hands-on experience with laboratory automation platforms and automated workflow integration of analytical methods in QC or AD environment.
  • Experience supporting automated liquid handlers such as Hamilton, Duet, Tecan, or similar systems.
  • Understanding of QC workflows and sample processing operations.
  • Experience leading or supporting automation integration and cross-functional technical projects.
  • Familiarity with quality systems such as Veeva and working knowledge of cGMP environments, quality events (change control, deviations and CAPA) and data integrity expectations.
  • Strong communication, collaboration, and problem-solving skills.

Preferred Qualifications:

  • Experience in Hamilton and/or other cGMP automatic liquid handling instruments for QC assays.
  • Experience in various cell therapy analytical techniques including Flow cytometry, and dPCR.

Education and Experience

  • B.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 2 years of relevant hands-on experience or
  • M.S. in Immunology, Cell Biology, Bioengineering, Analytical Sciences, or a related scientific discipline with 1 year of prior industry experience required.
 

Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.

About the Company

A

Ampcus Incorporated

Ampcus Inc is a global technology and business consulting firm specializing in Digital Transforrmation, Big Data, Analytics, Cyber Security, Testing, IV&V, Infrastructure Management and Enterprise Solutions. Ampcus Inc is an SBA 8(a) certified Women and Minority Owned global Provider of broad range of consulting Services. From strategy to execution, our disciplined yet flexible approach starts and ends with our clients. By listening hard and working harder, their goals become our goals. We are an ISO 9000, ISO 20000, ISO 27000 and CMMi Level certified company.

Ampcus consultants have significant business, engineering and technology experience. Our consultants have over 20 years of business experience and an average of over 10 years of engineering and technology experience. This means that the project teams understand how systems work and how the technology impacts the business processes of organizations.

We believe that success of an engagement is determined by strong project management, clear communication and mutual commitment working collaboratively. Our methodology begins by listening to the customer needs, then working with their teams to gain a clear understanding of the requirements, while providing a knowledge transfer of best practices for the organization. As a recognized leader providing customized software services, management and engineering solutions to companies around the world, our ability to deliver is a "granted"​ that makes companies put their trust in us to answer their day-to-day business challenges and put them on a path for greater success. We are the choice for our clients because we look at our clients business from a growth perspective.

Industry: Information Technology and Services

Specialties: Digital Transformation, Big Data and Analytics, Infrastructure Management Services, Testing and IV&V, Cyber Security, Active Directory and E-mail Infrastructure, Project Management, Training, and ERP, CRM. EAI, BI

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
http://www.ampcus.com