QC Associate (Biology / Microbiology) (Thousand Oaks)

Ideal Candidate: Background in biology experience. Exposure to GMP and Aseptic technique 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 SmartLab (LMES) with efficiency and accuracy.

Job Summary

This position is a unique opportunity to work within Quality Control at 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.

Basic Qualifications

• High school/GED and 2 years work or military experience OR Associates and 6 months work or military experience

Top 3 Must Have Skill Sets:

• Analytical & Instrumentation Proficiency
• Regulatory & Compliance Expertise (GxP)
• Data Integrity & Documentation Discipline

Day to Day Responsibilities:

• 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.