MCS Associate Quality Control - The Steely Group

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.

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