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MCS Associate Quality Control

Thousand Oaks, CA
Description:
Note:
  • 100% Thousand Oaks, CA
  • Local candidates really need to be able to make commute to site
  • Schedule is flexible ideally: 7am- 4pm (possible weekend and holiday work, not frequent once a month potentially)

Ideal Candidate:
  • Background in biology experience. Exposure to GMP and Aseptic technic and benchwork experience. Lab work.
  • Support Microbiology lab with analytical testing. Pipetting water testing, Observing for colonies on Agar plates.
  • Working in a laminar flow hood. Work with Laboratory Information Management System (LIMS) and/ or Smart Lab (LMES) with efficiency and accuracy.

Job Summary
  • This position is a unique opportunity to work within Quality Control at the Thousand Oaks site and to directly support both manufacturing and Quality Control operations.
  • Under minimal supervision analyze environmental monitoring samples, cross check sample requirements against SOPs and enter results in a laboratory information management system (LIMS) and/ or SmartLab (LMES). This position will work in a team environment, collaborating within the lab as well as with various colleagues in the network.

Key Responsibilities:
  • At all times, align with safety guidelines from EHSS, cGMPs, and other applicable regulatory requirements.
  • Adhere to good documentation practices.
  • Complete all required training before starting any tasks.
  • Work with Laboratory Information Management System (LIMS) and/ or SmartLab (LMES) with efficiency and accuracy.
  • Ability to manage and coordinate all tasks assigned and effectively complete all expected deliverables in a timely manner.
  • Ensure equipment preventive maintenance are performed per requirements and by due date as assigned.
  • Participate in the investigation of out-of-specification and/ or non-conforming test results.
  • Supports internal and external inspections and audits as needed (lab preparation, data retrieval etc.).
  • Troubleshoot, solve problems, and communicate with relevant team members.
  • Implement prevention or corrective actions based on lab manager feedback.
  • Perform QC Support tasks e.g., organization and cleaning of the lab, checking to ensure removal of expired media performed, archiving documentation, preliminary plate readings etc.
  • Support Microbiology lab with analytical testing.
  • Implementation of lab improvements to ensure an efficient and productive lab environment.
  • Must be willing to work an on-site Monday-Friday (7am- 4pm) work schedule and possibly weekend and holiday work based on requirements and business needs.

Basic Qualifications:
  • Bachelor’s degree in relevant scientific discipline or other appropriate specialty such as Life Sciences and one-year related experience or an equivalent combination of education and relevant work experience.
  • Physical Requirements:
  • Frequently sit, grasp lightly, use fine hand manipulation, repetitive handling of agar plates, perform desk-based computer tasks, and lift, carry, push, and pull objects up to 15 pounds.

Working Conditions:
  • Employee must perform tasks that require the use of personal protective equipment, such as safety glasses and shoes, lab coats and gloves, and possibly a mask.

Preferred Qualifications:
  • GxP experience, specifically practices and requirements in the testing of biopharmaceuticals.
  • Experience using various QC systems such as CDOCS (Veeva Vault), LIMS and/or SmartLab (LMES).
  • Experience and knowledge of Data Integrity Requirements in QC systems.
  • Proficient in Microsoft Office (i.e., Outlook, Word, Excel, PowerPoint).
  • Excellent problem-solving capabilities and attention to detail in delivering right first-time results.
  • Experience of collaboration within and across functional areas.
  • Excellent written, verbal communication, organizational skills, and attention to details.

Top 3 Must Have Skill Sets:    
  • Aseptic technic
  • Lab Experience
  • Communication, Problem solving, teamwork

Pay Rate- between $23 - $27/Hr on W2 based on experience.

"This posting is for Contingent Worker, not an FTE"

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