Quality Control Associate

Hitachi Chemical Advanced Therapeutics Solutions, LLC - Mountain View, CA3.8

Full-timeEstimated: $67,000 - $89,000 a year
EducationSkills

Quality Control Associate

The QC Associate I and QC Associate II are responsible for performing Quality control activities with minimal supervision of daily tasks in support of HCATS and client procedures. Procedures are expected to be performed with precision and accuracy and demonstrate a high level of documentation accuracy and clarity. Compliant with all applicable SOP’s and good documentation practices as well as cGMP and cGTP requirements. Identify problems that may adversely affect test performance or reporting of test results, correct the problems encountered or immediately notify your manager. Document all corrective actions taken when test systems deviate from the laboratories established performance specifications.

Essential Functions and Responsibilities

QC I:

Perform the accurate execution of test methods and procedures
Maintain inventory of QC materials and lab supplies, including monitoring and ordering
Perform maintenance, monitoring, and troubleshooting of pertinent equipment
Perform reagent and media preparation
Compliant with all applicable SOPs and good documentation practices(GDP) as well as cGMP/GCTP requirements
Conduct test, review and release test results for products or materials
Perform and assist in equipment qualification and method validations as needed
Perform state proficiency testing and/or client proficiency testing under direct supervision as applicable
Investigate Out of Specification (OOS), Out of Trend (OOT) and/or non-conforming test results
Assist in investigations, and preparation of deviation reports, with input from the manager or lead, in a timely manner and implements corrective actions and preventive actions
Packaging and shipping samples to contracted Laboratories for testing and/or to Clients

QC II:

Responsibilities include those for QC Associate I in addition to those below.
Interacts with clients during routine team meetings and on technology transfer projects
Develops Standard Operating Procedures, Work Instructions, and associated materials
Trains new QC associates I
Manages and drives resolution of quality issues with clients, collaborators and internal personnel

Qualifications

QC I:

Relevant college degree, Medical Technologist license or equivalent
Minimum of 0-1 years’ applicable experience in a clinical laboratory, microbiology, hematology, blood banking, immunology or QC laboratory preferably in a cGMP/cGTP environment.
Basic knowledge of Flow Cytometry experience preferred
Must be proficient in QC test methods/procedures and use of the QC lab equipment
Working knowledge of GxP regulations and standards
Working knowledge of quality systems: Change control, Deviations, CAPA, etc.

QC II:

Relevant college degree, Medical Technologist license or equivalent
Minimum of 1-3 years’ applicable experience in a clinical laboratory, microbiology, hematology, blood banking, immunology or QC laboratory preferably in a cGMP/cGTP environment.
Working knowledge of Flow Cytometry experience preferred
Must be proficient in QC test methods/procedures and use of the QC lab equipment
Working knowledge of GxP regulations and standards

Working knowledge of quality systems: Change control, Deviations, CAPA, etc.

Competencies/Candidate Profile

Relevant computer skills (Microsoft Office, Outlook)
Meticulous (Detail-oriented)
Organization skill
Strong collaborative skills
Analytical and problem-solving skills
Good written and oral communication skills
Flexible and able to adapt to company growth and evolving responsibilities
Ability to manage multiple tasks and changing priorities
Ability to work independently and with cross functional teams
Time management skills essential

Minimum Required Training to Be Completed within the first 90 Days of hire

GTP/GMP training

Supervisory Responsibilities

This job has no supervisory responsibilities.

Working Environment

Must have the ability to work in a team-oriented environment and with clients
Must be able to work during the weekend, holidays and as required by the company
May be exposed to infectious diseases transmittable through human blood, tissues, or bodily fluids
Must utilize proper personal protective equipment (PPE) when handling all human specimens, gases, corrosive chemicals, and liquid nitrogen
Must have the ability to work in the cleanroom environment for extended period of time
Must have the ability to work with specialized equipment
Must be able to handle the standard/moderate noise of the manufacturing facility

Physical Requirements

Must be physically capable to stand; walk; sit; bend; stretch; use hands to finger, handle or feel; reach with hands and arms; and talk or hear
The employee is frequently required to lift and/or move up to 30 pounds and occasionally move tanks up to 300 pounds (with assistance)
Heavy cryo-gloves must be used when working with liquid nitrogen

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.

About Us

Hitachi Chemical Advanced Therapeutics Solutions, LLC is an industry leader in contract development and manufacture of cell therapy products.

HCATS works with its clients to overcome the fundamental challenges of cell therapy manufacturing by providing a wide range of innovative services including product and process development, full scale cGMP/GLP manufacturing, engineering and automation, cell and tissue processing, logistics, storage and distribution, as well as expert consulting and regulatory support.

Our mission is to provide our clients with high quality, scalable, innovative, reliable, and cost efficient manufacturing platforms and services to advance commercialization of cellular therapies. We are in the business of developing innovative service products for cell therapy manufacture; selling these to senior leaders in charge of development programs in collaboration with their subject matter experts; and delivering these service products for the development and execution of cell-based therapy manufacturing directly to clinical and commercial development teams around the world.

Please connect with us on LinkedIn at https://www.linkedin.com/company/pct-cell-therapy-services

Follow us on Twitter @PCTcelltherapy

Job Type: Full-time

Job Type: Full-time

Experience:

  • relevant quality control: 2 years (Preferred)

Education:

  • Bachelor's (Required)

Location:

  • Mountain View, CA (Preferred)

Work authorization:

  • United States (Required)

Additional Compensation:

  • Commission

Work Location:

  • One location