Quality Control Associate

Job Details:

MCS Associate Quality Control in Thousand Oaks, CA

12 Months Contract

The schedule is flexible ideally: 7 am- 4 pm (possible weekend and holiday work, not frequent once a month potentially)

"Local candidates need to be able to make the commute to the site"

Job Summary:

• This position is a unique opportunity to work within Quality Control at the Company 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 Company 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 is performed per requirements and by the 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 (7 am- 4 pm) 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:

• Employees 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 in collaboration within and across functional areas.
• Excellent written, and verbal communication, organizational skills, and attention to detail.