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.